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Tricuspid RegurgitationNCT03904147

TRILUMINATE Pivotal Trial

A study testing TriClipTM Device in people with Tricuspid Regurgitation, run by Abbott Medical Devices at 76 sites in 5 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

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tricuspid Regurgitation
What is being tested?
TriClipTM Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
572 participants
Where
76 sitesin 5 countries
Study dates
21 Aug 2019to Apr 2029
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • In the judgment of the site local heart team, subject has been adequately treated per applicable standards (including medical management) and stable for at least 30 days as follows:
  • Optimized medical therapy for treatment of TR (e.g. diuretics).
  • Medical and/or device therapy, for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure.
  • The Eligibility Committee will confirm that the subject has been adequately treated medically.
  • Subject is symptomatic with Severe TR despite being optimally treated as described above. TR severity is determined by the assessment of a qualifying TTE and confirmed by the ECL. The ECL will also request a TEE to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s).
  • The cardiac surgeon of the site local heart team concur that the patient is at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
Show all 10Show fewer
  • New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV
  • In the judgment of the TriClip(TM) implanting Investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.
  • Age ≥18 years at time of consent.
  • Subject must provide written informed consent prior to any trial related procedure.

Who cannot join

  • Systolic pulmonary artery pressure (sPAP) > 70 mmHg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization (RHC)
  • Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg
  • Any prior tricuspid valve procedure that would interfere with placement of the TriClip(TM) device
  • Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction prior 60 days. Note: Patients with concomitant Mitral and tricuspid valve disease will have the option of getting their MR treated, and wait 60 days prior to being reassessed for the trial.
  • Pacemaker or ICD leads that would prevent appropriate placement of the TriClip(TM) clip.
  • Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥5 mmHg as measured by the ECL
Show all 31Show fewer
  • Left Ventricular Ejection Fraction (LVEF) ≤20%
  • Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:
  • Evidence of calcification in the grasping area
  • Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets
  • Severe leaflet defect(s) preventing proper device placement
  • Ebstein Anomaly - Identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle.
  • Tricuspid valve anatomy not evaluable by TTE and TEE
  • Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated).
  • MI or known unstable angina within prior 30 days
  • Percutaneous coronary intervention within prior 30 days
  • Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
  • Cerebrovascular Accident (CVA) within prior 90 days
  • Chronic dialysis
  • Bleeding disorders or hypercoagulable state
  • Active peptic ulcer or active gastrointestinal (GI) bleeding
  • Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy.
  • Note: Contraindication to either antiplatelet or anticoagulant therapy (individually not both therapies) is not an exclusion criterion.
  • Ongoing infection requiring current antibiotic therapy (if temporary illness, patients may enroll 30 days after discontinuation of antibiotics with no active infection).
  • Known allergy or hypersensitivity to device materials
  • Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
  • Life expectancy of less than 12 months
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  • Subject is currently participating in another clinical investigation for valvular heart disease(s).
  • Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days of the baseline visit per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.) It is accepted, in certain cases, to include subjects having a sterilized regular partner or subjects using a double barrier contraceptive method.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Trial locations and contacts

76 sites in 5 countries.

76 sites in 5 countries

United States63 sites

  • Albany Medical Center

    Albany, New York, 12208

  • University of Michigan

    Ann Arbor, Michigan, 48104

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • JFK Medical Center

    Atlantis, Florida, 33462

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Austin Heart

    Austin, Texas, 78756

  • University Hospital - University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Manatee Memorial Hospital

    Bradenton, Florida, 34208

  • Buffalo General Hospital

    Buffalo, New York, 14203

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Novant Health Heart and Vascular Research Institute

    Charlotte, North Carolina, 28204

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • Morton Plant Valve Clinic

    Clearwater, Florida, 33756

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

  • Baylor Scott and White Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Delray Medical Center

    Delray Beach, Florida, 33484

  • Northshore University HealthSystem

    Evanston, Illinois, 60201

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70361

  • The Methodist Hospital

    Houston, Texas, 77030

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782

  • St. Vincent Hospital

    Indianapolis, Indiana, 46240

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Scripps Green Hospital

    La Jolla, California, 92037

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Aurora Medical Group

    Milwaukee, Wisconsin, 53215

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • El Camino Hospital

    Mountain View, California, 94040

  • Intermountain Medical Center

    Murray, Utah, 84157

  • Centennial Heart Cardiovascular Consultants

    Nashville, Tennessee, 37203

  • St. Thomas Hospital

    Nashville, Tennessee, 37205

  • Yale New Haven

    New Haven, Connecticut, 06510

  • Mount Sinai Hospital

    New York, New York, 10029

  • New York-Presbyterian/Columbia University Medical Center

    New York, New York, 10032

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Providence Medical Foundation (St. Joseph Hospital)

    Orange, California, 92868

  • Palm Beach Garden Medical Center

    Palm Beach Gardens, Florida, 33410

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • St. Joseph's Hospital & Medical Center

    Phoenix, Arizona, 85013

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Providence Heart and Vascular Institute

    Portland, Oregon, 97225

  • Sutter Medical Center, Sacramento

    Sacramento, California, 95816

  • University of California - Davis Medical Center

    Sacramento, California, 95817

  • Methodist Hospital of San Antonio

    San Antonio, Texas, 78229

  • California Pacific Medical Center

    San Francisco, California, 94109

  • Scottsdale Healthcare Shea

    Scottsdale, Arizona, 85260

  • Swedish Medical Center

    Seattle, Washington, 98107

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • Montefiore Medical Center - Moses Division

    The Bronx, New York, 10467

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360

  • Tucson Medical Center

    Tucson, Arizona, 85712

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226

Other trials in United States

Canada7 sites

  • Hamilton Health Science Centre

    Hamilton, Ontario, L8L 2X2

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montreal, Quebec, H1T 1C8

  • The Royal Victoria

    Montreal, Quebec, H4A 3J1

  • Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Sunnybrook Health Science Centre

    Toronto, Ontario, M5N 3M5

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 2E8

Other trials in Canada

Germany4 sites

  • Universitätsklinikum Bonn AdöR

    Bonn, North Rhine-Westphalia, 53105

  • Herzzentrum Leipzig GmbH

    Leipzig, Saxony, 04289

  • UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • München Grosshadern

    München, Bavaria, 81377

Other trials in Germany

Italy1 site

  • Ospedale San Raffaele - Cardiac

    Milan, Lombard, 20132

Other trials in Italy

Spain1 site

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, Catalonia, 08036

Other trials in Spain

About this study

Official title: Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).

Being tested
TriClipTM Device
Keywords
ABT-CIP-10249, Tricuspid, Cardiovascular, Pivotal
Medical subject headings
Tricuspid Valve Insufficiency

What participants receive

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

  • TriClipTM DeviceDevice

    Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation

Study groups in NCT03904147
Study groupRoleWhat they receive
Randomized - Device GroupExperimentalSubjects will undergo TriClip implantation and will continue to be managed on medical therapy, per physician discretion
Receives: Device: TriClipTM Device
Randomized - Control GroupActive comparatorSubjects will continue to be managed on medical therapy, per physician discretion
Receives: Device: TriClipTM Device
Single Arm GroupExperimentalSubjects will receive the TriClip device and will continue to be managed on medical therapy, per physician discretion.
Receives: Device: TriClipTM Device
Continued Access Study (CAS)ExperimentalSubjects will undergo TriClip implantation and will continue to be managed on medical therapy, per physician discretion
Receives: Device: TriClipTM Device

What is being measured

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

  1. For Randomized Cohort: Hierarchical Composite of All-cause Death or Tricuspid Valve Surgery, Heart Failure Hospitalizations, and KCCQ Improvement

    Analysis of hierarchical composite of all-cause death or tricuspid valve surgery, heart failure hospitalizations, and KCCQ improvement of at least 15 points was performed in ITT population using Finkelstein-Schoenfeld method.

    A win ratio was also calculated to descriptively quantify the magnitude of treatment benefits. The win ratio is calculated as the ratio of the number of wins in Device versus Control patients. The primary analysis population consisted of 175 Device patients and 175 Control patients, resulting in 30,625 Device-Control patient pairs (i.e., 175 × 175).

    Measured: 12 Months

  2. For Single-Arm Cohort: Rate of Survival Through 12 Months With a Quality of Life Improvement (Assessed Using KCCQ Overall Score) of at Least 10 Points Compared to Baseline.

    This outcome will be assessed as the percentage of subjects meeting the definition of the endpoint.

    Measured: 12 months

Secondary outcomes (9)

  1. For Randomized Cohort - Device Group Only: Rate of Kaplan-Meier Estimate (SE) of Freedom From Major Adverse Events (MAE) Occurring Within 30 Days Post-procedure

    Freedom from major adverse events (MAE) was assessed in the Attempted Procedure population (n=172). MAEs included cardiovascular mortality, new onset renal failure, endocarditis requiring surgery, and non-elective cardiovascular surgery for TriClip device-related AE post-index procedure.

    Measured: 30 Days

  2. For Randomized Cohort: Change in Quality of Life as Assessed by KCCQ Score

    The mean change in KCCQ score between 12 months and baseline in the Device and Control groups will be compared, while adjusting for the baseline KCCQ score. The primary analysis for this endpoint imputed a KCCQ score of 0 at 12-month visit for all subjects who experienced a heart failure related cardiovascular death or received tricuspid valve surgery prior to completing 12-month follow-up. All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status.

    Measured: 12 months minus baseline

  3. For Randomized Cohort: Tricuspid Regurgitation Reduction to Moderate or Less at 30-Day Visit

    The percentage of subjects with tricuspid regurgitation reduced to moderate or less at 30-day visit in the Device Group will be compared with that in the Control Group. Tricuspid regurgitation severity will be graded on a 5-point scale: trace/mild, moderate, severe (severe 3), massive (severe 4), and torrential (severe 5), which has frequently been used in recent interventional tricuspid studies to categorize tricuspid regurgitation severity. This grading system follows the 2017 ASE guidelines (Zoghbi WA, Adams D, Bonow RO et al. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr 2017;30:303-371.), and further stratifies the traditional "severe" category into severe (Severe 3), massive (Severe 4), and torrential (Severe 5).

    Measured: 30 Days

  4. For Randomized Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months

    The primary analysis for this endpoint imputed a 6MWT distance of 0 meters for all subjects who experienced a heart failure related cardiovascular death or received tricuspid valve surgery prior to completing 12-month follow-up. Subjects who were unable to exercise due to cardiac reasons were also assigned a 6MWT distance of 0 meters at 12-month follow-up. Other subjects with missing 6MWT distance at either baseline or 12-month follow-up were excluded from the analysis.

    Measured: 12 Months

  5. For Single-Arm Cohort: The Percentage of Subjects With TR Reduction by at Least 1 Grade at 30-Day Follow-up

    Measured: 30 days

  6. For Single-Arm Cohort: Rate of Freedom From MAE Through 30 Days

    Freedom from MAE occurring after procedure attempt (femoral vein puncture) at 30 days. Components of MAE consist of Cardiovascular Mortality, New Onset Renal Failure, Endocarditis Requiring Surgery, and Non-Elective Cardiovascular Surgery for TriClip device-related AE post-index procedure.

    Measured: 30 days

  7. For Single-Arm Cohort: Change in 6 Minute Walk Test (6MWT) From Baseline to 12 Months

    This analysis imputed a 6MWT distance of 0 meters for all subjects who were unable to exercise due to cardiac reasons. However, there were no subjects unable to exercise due to cardiac reasons and therefore no imputation was performed. Subjects with missing 6MWT distance at either baseline or 12-month follow-up were excluded from the analysis.

    Measured: 12 months

  8. Recurrent HF Hospitalizations at 24 Months

    H0: HR(24M)>1; H1: HR(24M)≤1

    Measured: 24 months

  9. Freedom From All-cause Mortality, Tricuspid Valve Surgery, and Tricuspid Valve Intervention at 24 Months

    H0: Survival curves of the two groups through 24 months are the same. H1: Survival curves of the two groups through 24 months are different.

    Measured: 24 months

Timeline

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

  1. First posted5 Apr 2019
  2. Study start21 Aug 2019
  3. Primary completion18 Nov 2022
  4. Study completionApr 2029 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
572 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03904147
Sponsor's protocol ID
ABT-CIP-10249
Status last verified
Dec 2024
First submitted
3 Apr 2019
Last updated
19 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Kar S, Makkar RR, Whisenant BK, Hamid N, Naik H, Tadros P, Price MJ, Singh G, Schwartz JG, Kapadia S, Alli O, Horr S, Seshiah P, Batchelor W, Jones BM, Ahmed MI, Benza R, Jorde U, Thourani VH, Ghobrial AA, Tang GHL, Trusty PM, Huang D, Hahn RT, Adams DH, Sorajja P; TRILUMINATE Pivotal Investigators. Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Controlled Trial. Circulation. 2025 Jun 10;151(23):1630-1638. doi: 10.1161/CIRCULATIONAHA.125.074536. Epub 2025 Mar 30.

    PubMed 40159089

  • Naik H, Price MJ, Kapadia S, Whisenant BK, Tadros P, Makkar R, Asgar AW, Fam N, Tang GHL, Mehta SR, Byrne T, Singh G, Panaich SS, Peterman K, Trusty PM, Hamid N, Hahn RT, Adams DH, Sorajja P. Tricuspid Transcatheter Edge-to-Edge Repair in Patients With Transvalvular CIED Leads: The TRILUMINATE Pivotal Trial. JACC Clin Electrophysiol. 2025 May;11(5):1012-1020. doi: 10.1016/j.jacep.2025.01.001. Epub 2025 Jan 20.

    PubMed 39903153

  • Cavalcante JL, Scherer M, Fukui M, Lerakis S, Harb S, Pursnani A, Schwartz JG, Kapadia S, Ricciardi MJ, Khalique O, Kodali S, Shah D, Little SH, Sekaran N, Whisenant B, Flueckiger P, Yadav P, Emaminia A, Batchelor W, Kellman P, Lin Z, Trusty PM, Hahn RT, Adams D, Sorajja P. Advanced Imaging Assessment of the Impact of Tricuspid Regurgitation on Cardiac Remodeling: The TRILUMINATE Pivotal Imaging Substudy. J Am Coll Cardiol. 2025 Jan 28;85(3):250-261. doi: 10.1016/j.jacc.2024.09.009. Epub 2024 Nov 20.

    PubMed 39570246

  • Jorde UP, Benza R, McCarthy PM, Ailawadi G, Whisenant B, Makkar R, Tadros P, Naik H, Fam N, Sauer AJ, Murthy S, Kar S, von Bardeleben RS, Hahn RT, Hamid N, Zbinden J, Sorajja P, Adams D. Impact of Renal and Liver Function on Clinical Outcomes Following Tricuspid Valve Transcatheter Edge-to-Edge Repair. J Am Coll Cardiol. 2024 Dec 17;84(25):2446-2456. doi: 10.1016/j.jacc.2024.08.044. Epub 2024 Aug 31.

    PubMed 39222896

  • Sorajja P, Whisenant B, Hamid N, Naik H, Makkar R, Tadros P, Price MJ, Singh G, Fam N, Kar S, Schwartz JG, Mehta S, Bae R, Sekaran N, Warner T, Makar M, Zorn G, Spinner EM, Trusty PM, Benza R, Jorde U, McCarthy P, Thourani V, Tang GHL, Hahn RT, Adams DH; TRILUMINATE Pivotal Investigators. Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med. 2023 May 18;388(20):1833-1842. doi: 10.1056/NEJMoa2300525. Epub 2023 Mar 4.

    PubMed 36876753

Questions about this trial

What is this clinical trial studying?

A study testing TriClipTM Device in people with Tricuspid Regurgitation, run by Abbott Medical Devices at 76 sites in 5 countries.

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 10 inclusion and 31 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 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Canada, Germany, Italy, Spain. 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?

Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

For Randomized Cohort: Hierarchical Composite of All-cause Death or Tricuspid Valve Surgery, Heart Failure Hospitalizations, and KCCQ Improvement (time frame: 12 Months). The study lists 2 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 NCT03904147, 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 19 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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