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Tricuspid RegurgitationCLASP II TRNCT04097145

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

A study testing Edwards PASCAL System and Optimal Medical Therapy in people with Tricuspid Regurgitation and Tricuspid Valve Insufficiency, run by Edwards Lifesciences at 79 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Edwards PASCAL System and Optimal Medical Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,270 participants
Where
79 sitesin 2 countries
Study dates
11 Dec 2019to 31 Dec 2031
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

  • Eighteen (18) years of age or older
  • Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
  • Severe or greater tricuspid regurgitation
  • New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
  • Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team
  • Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements

Who cannot join

  • Tricuspid valve anatomy not evaluable by TTE or TEE
  • Tricuspid valve anatomy precludes proper device deployment and function
  • Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure)
  • Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:
  • Would prevent proper TR reduction due to interaction of the lead with the leaflets
  • Were implanted in the RV within the last 90 days prior to the point of enrollment
Show all 30Show fewer
  • Primary non-degenerative tricuspid disease
  • Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL
  • Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction
  • Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment
  • Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days
  • Recent Stroke
  • Active gastrointestinal (GI) bleeding
  • Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease, including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenic RV
  • Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days
  • Any of the following cardiovascular procedures:
  • Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment
  • Carotid surgery within 30 days prior to the point of enrollment
  • Direct current cardioversion within the last 30 days prior to the point of enrollment
  • Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment
  • Cardiac surgery within 90 days prior to the point of enrollment
  • Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
  • Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis
  • Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days
  • Patient is oxygen-dependent or requires continuous home oxygen
  • Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days)
  • Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
  • Patient is currently participating in another investigational biologic, drug, or device clinical study
  • Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship
  • Any patient considered to be vulnerable

Trial locations and contacts

79 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Edwards TMTT Clinical Affairs contact

(949) 250-2500

CLASPIITRTrialMgmt@edwards.com

79 sites in 2 countries

United States73 sites, 45 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Stanley Chetcuti, MD

    Recruiting

  • Emory University Hospital Midtown / Emory University - St. Joseph's Hospital

    Atlanta, Georgia, 30308

    Adam Greenbaum, MD

    Recruiting

  • Piedmont Healthcare, Inc.

    Atlanta, Georgia, 30309

    Active, not recruiting

  • Johns Hopkins

    Baltimore, Maryland, 21287

    Rani Hasan, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Nilay Patel, MD

    Ignacio Inglessis, MD

    Recruiting

  • State University of New York at Buffalo

    Buffalo, New York, 14203

    Vijay Iyer, MD, PhD

    Recruiting

  • Cooper Health Systems

    Camden, New Jersey, 09103

    Sajjad Sabir, MD

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27517

    John Vavalle, MD

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29245

    Active, not recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

    John Saxon, MD

    Recruiting

  • Erlanger Health System

    Chattanooga, Tennessee, 37403

    Active, not recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Charles Davidson, MD

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    Santiago Garcia, MD

    Recruiting

  • TriHealth-Bethesda North Hospital

    Cincinnati, Ohio, 45242

    Active, not recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Konstantinos Boudoulas, MD

    Scott Lilly, MD

    Recruiting

  • St. Joseph Hospital

    Denver, Colorado, 80218

    Jake Chanin, MD

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Brian O' Neill, MD

    Recruiting

  • Sanford Medical Center Fargo

    Fargo, North Dakota, 58104

    Active, not recruiting

  • The Cardiac and Vascular Institute Research Foundation

    Gainesville, Florida, 32605

    Charles Klodell, MD

    Ilie Barb, MD

    Recruiting

  • Penn State Hershey

    Hershey, Pennsylvania, 17033

    Mark Kozak, MD

    Recruiting

  • HCA Houston Healthcare Medical Center

    Houston, Texas, 77004

    Pranav Loyalka, MD

    Recruiting

  • Baylor College of Medicine St. Luke's Medical Center

    Houston, Texas, 77030

    Guilherme Silva, MD

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Abhijeet Dhoble, MD

    Richard Smalling, MD

    Recruiting

  • UTHealth/Memorial Hermann Hospital

    Houston, Texas, 77030

    Biswajit Kar, MD

    Recruiting

  • Ascension St. Vincent Heart Center Cardiovascular Research Institute

    Indianapolis, Indiana, 46290

    James Hermiller, MD

    Recruiting

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

    Active, not recruiting

  • University of California, Irvine

    Irvine, California, 92868

    Antonio Frangieh, MD

    Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Adnan Chhatriwalla, MD

    Recruiting

  • SCPMG - Kaiser San Diego

    La Jolla, California, 92037

    Active, not recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Michael Young, MD

    Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Active, not recruiting

  • UCLA Medical Center

    Los Angeles, California, 90095

    Active, not recruiting

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

    Active, not recruiting

  • Fairview Health Services

    Maplewood, Minnesota, 55109

    Active, not recruiting

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

    Nirat Beohar, MD

    Steve Xydas, MD

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Jeremiah Depta, MD

    Recruiting

  • Providence St. Patrick Hospital

    Missoula, Montana, 59802

    Active, not recruiting

  • Morristown Medical Center

    Morristown, New Jersey, 07962

    Gennaro Giustino, MD

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107

    Active, not recruiting

  • NCH Healthcare System

    Naples, Florida, 34102

    Robert Cubeddu, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

    Active, not recruiting

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

    Mark Russo, MD

    Recruiting

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

    Active, not recruiting

  • Columbia University Irving Medical Center/NYPH

    New York, New York, 10032

    Michael Brener, MD

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10065

    Shmuel Chen, MD

    Recruiting

  • Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset

    New York, New York, 10075

    Mei Chau, MD

    Bruce Rutkin, MD

    Recruiting

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

    Active, not recruiting

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120

    Mohammad Ghani, MD

    Recruiting

  • Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Active, not recruiting

  • Banner University Medical Center Phoenix

    Phoenix, Arizona, 85006

    Active, not recruiting

  • Baylor Scott & White - The Heart Hospital - Plano

    Plano, Texas, 75093

    Molly Szerlip, MD

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Firas Zahr, MD

    Scott Chadderdon, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Active, not recruiting

  • Carilion Medical Center

    Roanoke, Virginia, 24014

    Jason Foerst, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Mackram Eleid, MD

    Recruiting

  • Rochester General Hospital

    Rochester, New York, 14621

    Active, not recruiting

  • St. Francis Hospital

    Roslyn, New York, 11576

    George A. Petrossian, MD

    Newell B. Robinson, MD

    Recruiting

  • William Beaumont Hospital - Royal Oak

    Royal Oak, Michigan, 48073

    Active, not recruiting

  • St. Mary's of Ascension Research

    Saginaw, Michigan, 48601

    Active, not recruiting

  • Kaiser Permanente San Francisco

    San Francisco, California, 94118

    Active, not recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Sammy Elmariah, MD

    Recruiting

  • Sarasota Memorial Health Care System

    Sarasota, Florida, 34239

    Ricardo A. Yaryura, MD

    Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Ming Zhang, MD

    Recruiting

  • Swedish Medical Center

    Seattle, Washington, 98122

    Active, not recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Active, not recruiting

  • St. George Regional Hospital

    St. George, Utah, 84790

    Blake Gardner, MD

    Recruiting

  • Stanford University

    Stanford, California, 94305

    Active, not recruiting

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

    Active, not recruiting

  • Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital

    The Bronx, New York, 10467

    Mohamed A. Latib, MD

    Recruiting

  • Tucson Medical Center Healthcare

    Tucson, Arizona, 85712

    Active, not recruiting

  • Oklahoma Heart Institute at Hillcrest Medical Center

    Tulsa, Oklahoma, 74104

    Kamran Muhammad, MD

    Recruiting

  • Pinnacle Health Cardiovascular Institute/UPMC Pinnacle

    Wormleysburg, Pennsylvania, 17043

    Mubashir Mumtaz, MD

    Recruiting

  • Lankenau Heart Institute

    Wynnewood, Pennsylvania, 19096

    William Gray, MD

    Recruiting

Other trials in United States

Canada6 sites

  • Hamilton Health Services

    Hamilton, Ontario, L8L 2X2

    Active, not recruiting

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4Q7

    Active, not recruiting

  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

    Québec, Quebec, G1V 4G5

    Active, not recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Active, not recruiting

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

    Active, not recruiting

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

    Active, not recruiting

Other trials in Canada

About this study

Official title: A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Read the detailed description

A Prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation. Patients will be seen for follow-up visits at discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Being tested
Edwards PASCAL System, Optimal Medical Therapy
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.

  • Edwards PASCAL SystemDevice

    Also called Transcatheter tricuspid valve repair (TTVr)

    Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy

  • Optimal Medical TherapyDrug

    Optimal Medical Therapy alone in patients with tricuspid regurgitation

  • Edwards PASCAL SystemDevice

    Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT

  • Edwards PASCAL SystemDevice

    Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Study groups in NCT04097145
Study groupRoleWhat they receive
Edwards PASCAL System & OMTExperimentalTranscatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Receives: Device: Edwards PASCAL System
Optimal Medical Therapy (OMT)Active comparatorOptimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Receives: Drug: Optimal Medical Therapy
Single-Arm RegistryExperimentalTranscatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
Receives: Device: Edwards PASCAL System
Continued Access StudyExperimentalTranscatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Receives: Device: Edwards PASCAL System

What is being measured

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

  1. Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score)

    Comparison of number of participants with composite endpoint events between experimental and active comparator arms

    Measured: 6 months

Secondary outcomes (15)

  1. 1 Grade Reduction in TR Severity

    Total number of participants with at least 1 grade reduction in TR severity

    Measured: 6, 12 months

  2. Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Change in KCCQ score from baseline

    Measured: 3, 6, and 12 months

  3. All Cause Mortality

    Total number of deaths from any cause

    Measured: 12 months, 24 months

  4. Death and Heart Failure Hospitalizations

    Total number of deaths and hospital admissions due to heart failure

    Measured: 12 months

  5. All-cause Mortality, TV Surgery or TV Interventions

    Total number of deaths, TV surgeries or interventions

    Measured: 24 months

  6. Right ventricular end-diastolic diameter (RVEDD mid)

    Change in right ventricular end-diastolic diameter (RVEDD mid)

    Measured: 12 months

  7. Major Adverse Events (MAEs)

    Overall rate of Major Adverse Events (MAEs)

    Measured: 30 days

  8. Reduction in TR grade

    Reduction in TR severity as assessed by TEE pre- and post-implantation

    Measured: Intraprocedural post-implantation

  9. All-Cause Mortality

    Total number of deaths from any cause

    Measured: 12 months, annually through 5 years

  10. Heart failure hospitalizations

    Total number of hospital admissions due to heart failure

    Measured: 12 months, annually through 5 years

  11. Non-elective tricuspid valve re-intervenitions (percutaneous or surgical)

    Total number of non-elective tricuspid valve re-interventions

    Measured: 12 months, annually through 5 years

  12. Durable RVAD implantation or heart transplant

    Total number of patients requiring RVAD impantantion or heart transplant

    Measured: 12 months, annually through 5 years

  13. Need for paracentesis

    Total nunber of patients who required paracentesis

    Measured: 12 months, annually through 5 years

  14. All cause mortality or the first heart failure hospitalization for patients with massive or torrential TR at baseline

    Time to death or first heart failure hospitalization

    Measured: 12, 24 months

  15. All-cause Hospitalizations

    Number of hospitalizations for any cause

    Measured: 12 months

Timeline

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

  1. First posted20 Sep 2019
  2. Study start11 Dec 2019
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2031 (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
None (open label)
Enrolment
1,270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04097145
Sponsor's protocol ID
2019-07
Acronym
CLASP II TR
Status last verified
Aug 2026
First submitted
18 Sep 2019
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Ailawadi G, Davidson CJ, Anderson AS, Hahn RT, Willert P, Gilmore SY, Vinekar C, Zhang B, Muralidhar M, Castro R, Shi L, Graham A, Feldman T, Mack MJ, Leon MB. Design and Rationale of the CLASP II TR Randomized Trial for Severe Tricuspid Regurgitation. Am Heart J. 2026 Oct 9:107627. doi: 10.1016/j.ahj.2026.107627. Online ahead of print.

    PubMed 42855029

Questions about this trial

What is this clinical trial studying?

A study testing Edwards PASCAL System and Optimal Medical Therapy in people with Tricuspid Regurgitation and Tricuspid Valve Insufficiency, run by Edwards Lifesciences at 79 sites in 2 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 6 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in United States, Canada. 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?

Contact Edwards TMTT Clinical Affairs ((949) 250-2500, CLASPIITRTrialMgmt@edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score) (time frame: 6 months). 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 NCT04097145, which also lists 1 linked publication.

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 14 Sep 2026.

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