Tricuspid Valve RegurgitationNCT04482062

TRISCEND II Pivotal Trial

A study testing Edwards EVOQUE System and Optimal Medical Therapy in people with Tricuspid Valve Regurgitation and Tricuspid Valve Insufficiency, run by Edwards Lifesciences at 62 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
What is being tested?: Edwards EVOQUE System and Optimal Medical Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 864 participants
Where: 62 sitesin 2 countries
Study dates: 9 Apr 2021to 27 Jun 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years old
Despite medical therapy (OMT) per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. Patient must be on OMT per the local heart team at the time of TR assessment for trial eligibility (TTE). OMT includes stable oral diuretic medications, unless patient has a documented history of intolerance.
Functional and/or degenerative TR graded as at least severe on a transthoracic echocardiogram (assessed by the echo core lab using a 5-grade classification)
The Local Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
Patient is willing and able to comply with all study evaluations and provides written informed consent.

Who cannot join

Anatomy precluding proper device delivery, deployment and/or function
LVEF < 25%
Evidence of severe right ventricular dysfunction
Any of the following pulmonary pressure parameters:
PASP >60 mmHg by echo Doppler (unless RHC demonstrates PASP ≤70 mmHg)
PASP >70 mmHg by RHC

Show all 50Show fewer

PVR >5 Wood units by RHC (unless PVR ≤5 Wood units and systolic BP >85 mmHg after vasodilator challenge)
Previous tricuspid surgery or intervention
Presence of trans-tricuspid pacemaker or defibrillator lead with any of the following:
Implanted in the RV within the last90 days
Patient is pacemaker dependent5 on trans-tricuspid lead without alternative pacing option
Has delivered appropriate ICD therapy
Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation.
Active endocarditis within the last 90 days or infection requiring antibiotic therapy (oral or intravenous) within the last 14 days
Hemodynamically significant pericardial effusion
Significant intra-cardiac mass, thrombus, or vegetation.
Clinically significant, untreated coronary artery disease requiring revascularization, evidence of acute coronary syndrome, recent myocardial infarction within the last 30 days.
Any of the following cardiovascular procedures:
Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days
Carotid surgery within the last 30 days
Direct current cardioversion within the last 30 days
Leadless RV pacemaker implant within the last 30 days
Cardiac surgery within the last 90 days
Known history of untreated severe symptomatic carotid stenosis (>50% by ultrasound) or asymptomatic carotid stenosis (>70% by ultrasound)
Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365days), or any planned percutaneous cardiac procedure within the next 90 days
Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or hemodynamic support within the last 30 days
Patient with refractory heart failure requiring or which required advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/AHA/ESC/EACTS Stage D heart failure)
Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 6 months (180 days)
Stroke within the last 90 days
Modified Rankin Scale ≥ 4 disability
Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73m2 or requiring chronic renal replacement therapy.
Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C
Patient is oxygen-dependent or requires continuous home oxygen
Chronic anemia with transfusion dependency or Hgb < 9 g/dL not corrected by transfusion
Unable to walk at least 100 meters in a 6-minute walk test
Thrombocytopenia (Platelet count < 75,000/mm3) or thrombocytosis (Platelet count > 750,000/mm3)
Known bleeding or clotting disorders or patient refuses blood transfusion
Active gastrointestinal (GI) bleeding within the last 90 days
Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days).
Patients in whom (any of the following):
TEE is contraindicated or cannot be completed
tricuspid valve anatomy is not evaluable by TTE or TEE
In the opinion of the investigator, access to and through the femoral vein/IVC with a guide sheath and delivery catheter is deemed not feasible (e.g. occluded femoral veins, occluded or thrombosed IVC filter)
Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media
Currently participating in another investigational biologic, drug or device study
Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to < 12 months (365 days).
Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant uncorrected congenital heart disease (including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV)
Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-ups
Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship
Any patient considered to be vulnerable

Trial locations and contacts

62 sites in 2 countries.

Country

City, postcode or hospital

62 sites in 2 countries

United States55 sites

University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30308
Piedmont Heart Institute
Atlanta, Georgia, 30309
Florida Heart & Vascular Care - JFK
Atlantis, Florida, 33462
University of Maryland
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
State University of New York at Buffalo
Buffalo, New York, 14203
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Virginia Health System
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
The Christ Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Health System
Detroit, Michigan, 48202
The Cardiac & Vascular Institute Research Foundation
Gainesville, Florida, 32605
HCA Houston Healthcare
Houston, Texas, 77004
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290
Kansas University Medical Center
Kansas City, Kansas, 66160
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Medical Center of the Rockies
Loveland, Colorado, 80538
North Shore University Hospital
Manhasset, New York, 11030
Morristown Medical Center
Morristown, New Jersey, 07960
Intermountain Medical Center
Murray, Utah, 84107
NCH Heart Institute
Naples, Florida, 34102
Saint Thomas Health
Nashville, Tennessee, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
NYU Langone Health
New York, New York, 10016
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, 10021
Columbia University Medical Center/NYPH
New York, New York, 10032
Lenox Hill Hospital
New York, New York, 10075
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
SJHMC Heart and Vascular Institute
Phoenix, Arizona, 85013
Baylor Heart Hopsital Plano
Plano, Texas, 75093
Oregon Health & Science University
Portland, Oregon, 97293
Mayo Clinic
Rochester, Minnesota, 55905
St. Francis Hospital
Roslyn, New York, 11576
UC Davis Medical Center
Sacramento, California, 95817
Kaiser Permanente San Francisco
San Francisco, California, 94118
University of California San Francisco
San Francisco, California, 94143
Virginia Mason Franciscan Health
Seattle, Washington, 98101
Swedish Medical Center
Seattle, Washington, 98122
University of Washington
Seattle, Washington, 98195
Stanford University
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10461
Tucson Medical Center
Tucson, Arizona, 85712
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
Ascension Via Christi St. Francis
Wichita, Kansas, 67214
Lankenau Heart Institute
Wynnewood, Pennsylvania, 19096

Other trials in United States

Germany7 sites

Herz- und Diabeteszentrum NRW, Bad Oeynhausen
Bad Oeynhausen, 32545
Herzzentrum Universitätsklinik Bonn
Bonn, 53105
Herzzentrum der Uniklinik Köln
Cologne, 50937
Herzzentrum Dresden Universitätsklinik
Dresden, 01307
Herzzentrum Leipzig GmbH
Leipzig, 04289
Johannes Gutenberg-Universität Mainz
Mainz, 55131
Klinikum der Universität München - Großhadern
München, 81377

Other trials in Germany

About this study

Official title: Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Read the detailed description

The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Conditions: Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure
Being tested: Edwards EVOQUE System, Optimal Medical Therapy
Medical subject headings: Tricuspid Valve Insufficiency, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Edwards EVOQUE SystemDevice
Also called Transcatheter tricuspid valve replacement
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
Optimal Medical TherapyDrug
Optimal Medical Therapy

Study groups in NCT04482062
Study group	Role	What they receive
Edwards EVOQUE System & OMT	Experimental	Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation Receives: Device: Edwards EVOQUE System
Optimal Medical Therapy (OMT)	Active comparator	Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation Receives: Drug: Optimal Medical Therapy
Single-Arm Registry	Experimental	Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization Receives: Device: Edwards EVOQUE System
Continued Access Study	Experimental	Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation. Receives: Device: Edwards EVOQUE System

What is being measured

The primary outcome is the main question the study is designed to answer.

Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction
Comparison of number of participants with reduction in TR between experimental and active comparator arms. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.
Measured: 6 months
Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement
Comparison of number of wins with composite endpoint event improvement between experimental and active comparator arms
Measured: 6 months
Randomized Cohort: Rate of Major Adverse Events (MAE)
Rate of Major Adverse Events (MAE) in experimental arm (Edwards EVOQUE System \& OMT)
Measured: 30 days
Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6MWD improvement
Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms
Measured: 1 year
Continued Access Study: Rate of Major Adverse Events (MAE)
Rate of MAEs in the Continued Access Study arm
Measured: 30 days
Continued Access Study: Tricuspid Regurgitation (TR) grade reduction to moderate, mild, or none/trace
TR grade reduction to moderate, mild, or none/trace from baseline. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential); Lower grades of TR are better.
Measured: 6 months
Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Improvement in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.
Measured: 6 months
Continued Access Study: New York Heart Association (NYHA) functional class
NYHA functional class improvement of at least 1 class. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).
Measured: 6 months
Continued Access Study: 6MWD
6MWD improvement of at least 30 meters
Measured: 6 months
Continued Access Study: All-cause mortality
Deaths from any cause
Measured: 1 year
Continued Access Study: Durable right ventricular assist device (RVAD) implantation or heart transplant
Durable RVAD implantation or heart transplant
Measured: 1 year
Continued Access Study: Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention
Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention.
Measured: 1 year
Continued Access Study: Annualized rate of heart failure hospitalizations
Annualized rate of heart failure hospitalizations
Measured: 1 year
Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Improvement in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.
Measured: 1 year
Continued Access Study: New York Heart Association (NYHA) functional class
NYHA functional class improvement of at least 1 class. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).
Measured: 1 year
Continued Access Study: 6MWD
6MWD improvement of at least 30 meters
Measured: 1 year

Secondary outcomes (45)

Randomized cohort: Tricuspid Regurgitation (TR) grade reduction
TR grade reduction from baseline to discharge (assessed up to 7 days post procedure). TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.
Measured: Time Frame: Discharge (assessed up to 7 days post procedure)
Randomized cohort: All-Cause Mortality
Total number of deaths from any cause
Measured: 1 year, annually through 5 years
Randomized cohort: Heart failure hospitalizations
Total number of patients with at least one hospital admission due to heart failure
Measured: 1 year, annually through 5 years
Randomized cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)
Total number of patients with at least one non-elective tricuspid valve re-intervention
Measured: 1 year, annually through 5 years
Randomized cohort: Durable RVAD implantation or heart transplant
Total number of patients requiring RVAD implantation or heart transplant
Measured: 1 year, annually through 5 years
Randomized cohort: Need for paracentesis
Total number of patients who required paracentesis
Measured: 1 year, annually through 5 years
Randomized cohort: Reduction in TR grade by at least one grade
Total number of patients with at least one grade TR reduction
Measured: 1 year
Randomized cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade
Total number of patients with NYHA functional class improvement of at least 1 class. The NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).
Measured: 1 year
Randomized cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
Change in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.
Measured: 1 year
Randomized cohort: Death and heart failure hospitalization
Comparison of number of wins with death and HFH between experimental and active comparator arms
Measured: 1 year
Randomized cohort: All-cause hospitalizations
Total number of patients with hospitalizations from any cause
Measured: 1 year
Randomized cohort: All-cause mortality
Total number of patients with deaths from any cause
Measured: 1 year
Randomized cohort: Change in 6MWD from baseline
Change in 6MWD from baseline
Measured: 1 year
Roll-in cohort: Tricuspid Regurgitation (TR) grade reduction
TR grade reduction from baseline to discharge (assessed up to 7 days post procedure). TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.
Measured: Time Frame: Discharge (assessed up to 7 days post procedure)
Roll-in cohort: All-cause mortality
Total number of deaths from any cause
Measured: 1 year, annually through 5 years
Roll-in cohort: Heart failure hospitalizations
Total number of hospital admissions due to heart failure
Measured: 1 year, annually through 5 years
Roll-in cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)
Total number of non-elective tricuspid valve re-interventions
Measured: 1 year, annually through 5 years
Roll-in cohort: Durable RVAD implantation or heart transplant
Total number of patients requiring RVAD implantation or heart transplant
Measured: 1 year, annually through 5 years
Roll-in cohort: Need for paracentesis
Total number of patients who required paracentesis
Measured: 1 year, annually through 5 years
Roll-in cohort: Reduction in tricuspid regurgitation (TR) grade by at least one grade
Total number of patients with at least one grade TR reduction. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.
Measured: 1 year
Roll-in cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade
Total number of patients with NYHA functional class improvement of at least 1 class. The NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).
Measured: 1 year
Roll-in cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
Change in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.
Measured: 1 year
Roll-in cohort: Death and heart failure hospitalization
Total number of patients with death or heart failure hospitalization
Measured: 1 year
Roll-in cohort: All-cause hospitalizations
Total number of patients with hospitalizations from any cause
Measured: 1 year
Roll-in cohort: All-cause mortality
Total number of patients with deaths from any cause
Measured: 1 year
Roll-in cohort: Change in 6MWD from baseline
Change in 6MWD from baseline
Measured: 1 year
Registry cohort: Tricuspid Regurgitation (TR) grade reduction
TR grade reduction from baseline to discharge. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.
Measured: Time Frame: Discharge (assessed up to 7 days post procedure)
Registry cohort: All-cause mortality
Total number of deaths from any cause
Measured: 1 year, annually through 5 years
Registry cohort: Heart failure hospitalizations
Total number of hospital admissions due to heart failure
Measured: 1 year, annually through 5 years
Registry cohort: Change in 6MWD from baseline
Change in 6MWD from baseline
Measured: 1 year
Registry cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)
Total number of non-elective tricuspid valve re-interventions
Measured: 1 year, annually through 5 years
Registry cohort: Durable RVAD implantation or heart transplant
Total number of patients requiring RVAD implantation or heart transplant
Measured: 1 year, annually through 5 years
Registry cohort: Need for paracentesis
Total number of patients who required paracentesis
Measured: 1 year, annually through 5 years
Registry cohort: Reduction in TR grade by at least one grade
Total number of patients with at least one grade TR reduction
Measured: 1 year
Registry cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade
Total number of patients with NYHA functional class improvement of at least 1 class. The NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).
Measured: 1 year
Registry cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
Change in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.
Measured: 1 year
Registry cohort: Death and heart failure hospitalization
Total number of patients with death and heart failure hospitalization
Measured: 1 year
Registry cohort: All-cause hospitalizations
Total number of patients with hospitalizations from any cause
Measured: 1 year
Registry cohort: All-cause mortality
Total number of patients with deaths from any cause
Measured: 1 year
Continued Access Study: Tricuspid Regurgitation (TR) grade reduction
TR grade reduction from baseline to discharge. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.
Measured: Time Frame: Discharge (assessed up to 7 days post procedure)
Continued Access Study: All-cause mortality
Total number of deaths from any cause
Measured: 1 year, annually through 5 years
Continued Access Study: Heart failure hospitalizations
Total number of hospital admissions due to heart failure
Measured: 1 year, annually through 5 years
Continued Access Study: Non-elective tricuspid valve re-intervention (percutaneous or surgical)
Total number of non-elective tricuspid valve re-interventions
Measured: 1 year, annually through 5 years
Continued Access Study: Durable RVAD implantation or heart transplant
Total number of patients requiring RVAD implantation or heart transplant
Measured: 1 year, annually through 5 years
Continued Access Study: Need for paracentesis
Total number of patients who required paracentesis
Measured: 1 year, annually through 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Apr 202127 Jun 2030

First posted22 Jul 2020
Study start9 Apr 2021
Primary completion5 Dec 2025
Study completion27 Jun 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Tricuspid Valve RegurgitationStudies of the same condition, open and under way.
More trials run by Edwards LifesciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 864 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04482062
Sponsor's protocol ID: 2020-05
Status last verified: Feb 2026
First submitted: 9 Jul 2020
Last updated: 27 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Sannino A, Grayburn PA, Kodali SK, Lurz P, Thourani VH, Makar M, Haeffele C, Puthumana J, Lee J, Flueckiger P, Chadderdon S, Padang R, Sekaran NK, Stewart-Dehner T, Ender J, Koulogiannis K, Morsy M, Miyasaka R, Havens B, Ku I, Silvestry F, Nabauer M, Gleason P, Lindman BR, Ho E, Good M, Gossler T, Cohen JA, Harris A, Sengupta P, Kelly N, Maksoud A, Weber M, Romero S, Yucel E, Raghunathan D, Skolnick D, Wang L, Sun YP, Vainrib A, Kapila A, Mackensen GB, Aman E, Mehrkens D, Ivannikova M, Smith W, Abramson S, Treat S, Toufan M, Mack MJ, Leon MB, Hahn RT; TRISCEND II Pivotal Trial Investigators. TRISCEND II: Effect of Transcatheter Tricuspid Valve Replacement on Echocardiographic Measures of Right Heart Remodeling and Function. JACC Cardiovasc Imaging. 2026 Sep;19(9):1027-1039. doi: 10.1016/j.jcmg.2026.05.019. Epub 2026 Jul 18.
PubMed 42470411
Arnold SV, Hahn RT, Thourani VH, Makkar R, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O'Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran N, Garcia S, Stewart-Dehner T, Grayburn PA, Sannino A, Snyder C, Zhang Y, Mack MJ, Leon MB, Lurz P, Kodali S, Cohen DJ; TRISCEND II Pivotal Trial Investigators. Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial. J Am Coll Cardiol. 2025 Jan 28;85(3):206-216. doi: 10.1016/j.jacc.2024.10.067. Epub 2024 Oct 30.
PubMed 39480380
Hahn RT, Makkar R, Thourani VH, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O'Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran NK, Garcia S, Stewart-Dehner T, Thiele H, Kipperman R, Koulogiannis K, Lim DS, Fowler D, Kapadia S, Harb SC, Grayburn PA, Sannino A, Mack MJ, Leon MB, Lurz P, Kodali SK; TRISCEND II Trial Investigators. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. N Engl J Med. 2025 Jan 9;392(2):115-126. doi: 10.1056/NEJMoa2401918. Epub 2024 Oct 30.
PubMed 39475399
Kodali S, Hahn RT, George I, Davidson CJ, Narang A, Zahr F, Chadderdon S, Smith R, Grayburn PA, O'Neill WW, Wang DD, Herrmann H, Silvestry F, Elmariah S, Inglessis I, Passeri J, Lim DS, Salerno M, Makar M, Mack MJ, Leon MB, Makkar R; TRISCEND Investigators. Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. JACC Cardiovasc Interv. 2022 Mar 14;15(5):471-480. doi: 10.1016/j.jcin.2022.01.016.
PubMed 35272771
Lurz P, Kresoja KP. Tricuspid Valve Therapies: Closing the Gap. JACC Cardiovasc Interv. 2021 Jun 14;14(11):1241-1242. doi: 10.1016/j.jcin.2021.04.008. No abstract available.
PubMed 34112461

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See locations

Recruiting
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
Recruiting
The TRICURE US IDE Pivotal Study
Tricuspid Regurgitation (TR)
Recruiting
EFS of the DUO System for Tricuspid Regurgitation
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Recruiting
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
Not yet recruiting
A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.
Tricuspid Valve Disease, Heart Valve Diseases

All Tricuspid Valve Regurgitation trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
ClinicalTrials.gov ID: NCT04482062
Acronym / sponsor ID: 2020-05
Conditions: Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 864 participants (actual)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Study start: 9 Apr 2021 (actual)
Primary completion: 5 Dec 2025 (actual)
Study completion: 27 Jun 2030 (estimated)
First posted: 22 Jul 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Edwards EVOQUE System & OMT	Experimental	Device: Edwards EVOQUE SystemTranscatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation
Optimal Medical Therapy (OMT)	Active comparator	Drug: Optimal Medical TherapyOptimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Single-Arm Registry	Experimental	Device: Edwards EVOQUE SystemTranscatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
Continued Access Study	Experimental	Device: Edwards EVOQUE SystemProvides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥ 18 years old
Despite medical therapy (OMT) per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. Patient must be on OMT per the local heart team at the time of TR assessment for trial eligibility (TTE). OMT includes stable oral diuretic medications, unless patient has a documented history of intolerance.
Functional and/or degenerative TR graded as at least severe on a transthoracic echocardiogram (assessed by the echo core lab using a 5-grade classification)
The Local Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
Patient is willing and able to comply with all study evaluations and provides written informed consent.

Key exclusion criteria (50 listed)

Anatomy precluding proper device delivery, deployment and/or function
LVEF < 25%
Evidence of severe right ventricular dysfunction
Any of the following pulmonary pressure parameters:
Previous tricuspid surgery or intervention

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Edwards EVOQUE SystemAlso: Transcatheter tricuspid valve replacementTranscatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT	Device	Continued Access Study, Edwards EVOQUE System & OMT, Single-Arm Registry
Optimal Medical TherapyOptimal Medical Therapy	Drug	Optimal Medical Therapy (OMT)

Primary outcome

Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction
Time frame: 6 months
Comparison of number of participants with reduction in TR between experimental and active comparator arms. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.
Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement
Time frame: 6 months
Comparison of number of wins with composite endpoint event improvement between experimental and active comparator arms
Randomized Cohort: Rate of Major Adverse Events (MAE)
Time frame: 30 days
Rate of Major Adverse Events (MAE) in experimental arm (Edwards EVOQUE System \& OMT)
Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6MWD improvement
Time frame: 1 year
Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms
Continued Access Study: Rate of Major Adverse Events (MAE)
Time frame: 30 days
Rate of MAEs in the Continued Access Study arm
Continued Access Study: Tricuspid Regurgitation (TR) grade reduction to moderate, mild, or none/trace
Time frame: 6 months
TR grade reduction to moderate, mild, or none/trace from baseline. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential); Lower grades of TR are better.
Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 6 months
Improvement in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.
Continued Access Study: New York Heart Association (NYHA) functional class
Time frame: 6 months
NYHA functional class improvement of at least 1 class. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).
Continued Access Study: 6MWD
Time frame: 6 months
6MWD improvement of at least 30 meters
Continued Access Study: All-cause mortality
Time frame: 1 year
Deaths from any cause
Continued Access Study: Durable right ventricular assist device (RVAD) implantation or heart transplant
Time frame: 1 year
Durable RVAD implantation or heart transplant
Continued Access Study: Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention
Time frame: 1 year
Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention.
Continued Access Study: Annualized rate of heart failure hospitalizations
Time frame: 1 year
Annualized rate of heart failure hospitalizations
Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 1 year
Improvement in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.
Continued Access Study: New York Heart Association (NYHA) functional class
Time frame: 1 year
NYHA functional class improvement of at least 1 class. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).
Continued Access Study: 6MWD
Time frame: 1 year
6MWD improvement of at least 30 meters

45 secondary outcomes

Randomized cohort: Tricuspid Regurgitation (TR) grade reduction
Time frame: Time Frame: Discharge (assessed up to 7 days post procedure)
Randomized cohort: All-Cause Mortality
Time frame: 1 year, annually through 5 years
Randomized cohort: Heart failure hospitalizations
Time frame: 1 year, annually through 5 years
Randomized cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)
Time frame: 1 year, annually through 5 years
Randomized cohort: Durable RVAD implantation or heart transplant
Time frame: 1 year, annually through 5 years
Randomized cohort: Need for paracentesis
Time frame: 1 year, annually through 5 years
Randomized cohort: Reduction in TR grade by at least one grade
Time frame: 1 year
Randomized cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade
Time frame: 1 year
Randomized cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
Time frame: 1 year
Randomized cohort: Death and heart failure hospitalization
Time frame: 1 year
Randomized cohort: All-cause hospitalizations
Time frame: 1 year
Randomized cohort: All-cause mortality
Time frame: 1 year
Randomized cohort: Change in 6MWD from baseline
Time frame: 1 year
Roll-in cohort: Tricuspid Regurgitation (TR) grade reduction
Time frame: Time Frame: Discharge (assessed up to 7 days post procedure)
Roll-in cohort: All-cause mortality
Time frame: 1 year, annually through 5 years
Roll-in cohort: Heart failure hospitalizations
Time frame: 1 year, annually through 5 years
Roll-in cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)
Time frame: 1 year, annually through 5 years
Roll-in cohort: Durable RVAD implantation or heart transplant
Time frame: 1 year, annually through 5 years
Roll-in cohort: Need for paracentesis
Time frame: 1 year, annually through 5 years
Roll-in cohort: Reduction in tricuspid regurgitation (TR) grade by at least one grade
Time frame: 1 year
Roll-in cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade
Time frame: 1 year
Roll-in cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
Time frame: 1 year
Roll-in cohort: Death and heart failure hospitalization
Time frame: 1 year
Roll-in cohort: All-cause hospitalizations
Time frame: 1 year
Roll-in cohort: All-cause mortality
Time frame: 1 year
Roll-in cohort: Change in 6MWD from baseline
Time frame: 1 year
Registry cohort: Tricuspid Regurgitation (TR) grade reduction
Time frame: Time Frame: Discharge (assessed up to 7 days post procedure)
Registry cohort: All-cause mortality
Time frame: 1 year, annually through 5 years
Registry cohort: Heart failure hospitalizations
Time frame: 1 year, annually through 5 years
Registry cohort: Change in 6MWD from baseline
Time frame: 1 year
Registry cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)
Time frame: 1 year, annually through 5 years
Registry cohort: Durable RVAD implantation or heart transplant
Time frame: 1 year, annually through 5 years
Registry cohort: Need for paracentesis
Time frame: 1 year, annually through 5 years
Registry cohort: Reduction in TR grade by at least one grade
Time frame: 1 year
Registry cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade
Time frame: 1 year
Registry cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
Time frame: 1 year
Registry cohort: Death and heart failure hospitalization
Time frame: 1 year
Registry cohort: All-cause hospitalizations
Time frame: 1 year
Registry cohort: All-cause mortality
Time frame: 1 year
Continued Access Study: Tricuspid Regurgitation (TR) grade reduction
Time frame: Time Frame: Discharge (assessed up to 7 days post procedure)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Derived from this study: PubMed 42470411Sannino A, Grayburn PA, Kodali SK, Lurz P, Thourani VH, Makar M, Haeffele C, Puthumana J, Lee J, Flueckiger P, Chadderdon S, Padang R, Sekaran NK, Stewart-Dehner T, Ender J, Koulogiannis K, Morsy M, Miyasaka R, Havens B, Ku I, Silvestry F, Nabauer M, Gleason P, Lindman BR, Ho E, Good M, Gossler T, Cohen JA, Harris A, Sengupta P, Kelly N, Maksoud A, Weber M, Romero S, Yucel E, Raghunathan D, Skolnick D, Wang L, Sun YP, Vainrib A, Kapila A, Mackensen GB, Aman E, Mehrkens D, Ivannikova M, Smith W, Abramson S, Treat S, Toufan M, Mack MJ, Leon MB, Hahn RT; TRISCEND II Pivotal Trial Investigators. TRISCEND II: Effect of Transcatheter Tricuspid Valve Replacement on Echocardiographic Measures of Right Heart Remodeling and Function. JACC Cardiovasc Imaging. 2026 Sep;19(9):1027-1039. doi: 10.1016/j.jcmg.2026.05.019. Epub 2026 Jul 18.
Derived from this study: PubMed 39480380Arnold SV, Hahn RT, Thourani VH, Makkar R, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O'Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran N, Garcia S, Stewart-Dehner T, Grayburn PA, Sannino A, Snyder C, Zhang Y, Mack MJ, Leon MB, Lurz P, Kodali S, Cohen DJ; TRISCEND II Pivotal Trial Investigators. Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial. J Am Coll Cardiol. 2025 Jan 28;85(3):206-216. doi: 10.1016/j.jacc.2024.10.067. Epub 2024 Oct 30.
Derived from this study: PubMed 39475399Hahn RT, Makkar R, Thourani VH, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O'Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran NK, Garcia S, Stewart-Dehner T, Thiele H, Kipperman R, Koulogiannis K, Lim DS, Fowler D, Kapadia S, Harb SC, Grayburn PA, Sannino A, Mack MJ, Leon MB, Lurz P, Kodali SK; TRISCEND II Trial Investigators. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. N Engl J Med. 2025 Jan 9;392(2):115-126. doi: 10.1056/NEJMoa2401918. Epub 2024 Oct 30.
Derived from this study: PubMed 35272771Kodali S, Hahn RT, George I, Davidson CJ, Narang A, Zahr F, Chadderdon S, Smith R, Grayburn PA, O'Neill WW, Wang DD, Herrmann H, Silvestry F, Elmariah S, Inglessis I, Passeri J, Lim DS, Salerno M, Makar M, Mack MJ, Leon MB, Makkar R; TRISCEND Investigators. Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. JACC Cardiovasc Interv. 2022 Mar 14;15(5):471-480. doi: 10.1016/j.jcin.2022.01.016.
Derived from this study: PubMed 34112461Lurz P, Kresoja KP. Tricuspid Valve Therapies: Closing the Gap. JACC Cardiovasc Interv. 2021 Jun 14;14(11):1241-1242. doi: 10.1016/j.jcin.2021.04.008. No abstract available.

Related trials for Tricuspid Valve Regurgitation

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First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rebecca Hahn, MD principal investigator

Columbia University

Susheel Kodali, MD principal investigator

Columbia University

Philipp Lurz, MD principal investigator

Herzzentrum Leipzig GmbH

62 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction (time frame: 6 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04482062, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.