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Tricuspid Valve RegurgitationNCT04221490

2019-06 TRISCEND Study

A study testing Transcatheter Tricuspid Valve Replacement in people with Tricuspid Valve Regurgitation and Heart Valve Diseases, run by Edwards Lifesciences at 20 sites in 4 countries.

Active, not recruiting

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

Official record
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Trial summary

Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Transcatheter Tricuspid Valve Replacement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
20 sitesin 4 countries
Study dates
6 May 2020to 31 Jan 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

  • Functional or degenerative TR moderate or greater
  • Symptomatic despite medical therapy or prior HF hospitalization from TR
  • The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement

Who cannot join

  • Tricuspid valve anatomic contraindications
  • Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
  • Hemodynamic instability
  • Refractory heart failure requiring advanced intervention
  • Currently participating in another investigational study in which the patient has not reached a primary endpoint

Trial locations and contacts

20 sites in 4 countries.

20 sites in 4 countries

United States14 sites

  • Emory University

    Atlanta, Georgia, 30308

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Massachusetts General Hospital Boston

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Northwestern University

    Evanston, Illinois, 60208

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Columbia University Irving Medical Center / NYPH

    New York, New York, 10032

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Baylor Heart Hopsital Plano

    Plano, Texas, 75093

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Stanford University

    Stanford, California, 94305

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

Canada3 sites

  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)

    Québec, G1V 4G5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • St. Paul's Hospital Vancouver

    Vancouver, British Columbia, V6Z1Y6

Other trials in Canada

France2 sites

  • CHU Bordeaux, Hôpital Cardiologique Haut Lévêque

    Pessac, 33600

  • Clinique Pasteur

    Toulouse, 31076

Other trials in France

Switzerland1 site

  • InselSpital University Hospital Bern

    Bern, 3010

Other trials in Switzerland

About this study

Official title: Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device

Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Read the detailed description

The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System.

Being tested
Transcatheter Tricuspid Valve Replacement
Keywords
Tricuspid Regurgitation, Transcatheter, Replacement, Functional, Degenerative, Regurgitation, Valve Replacement, Cardiovascular Disease
Medical subject headings
Tricuspid Valve Insufficiency, Heart Valve Diseases, Cardiovascular Diseases, Gastroesophageal Reflux

What participants receive

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

  • Transcatheter Tricuspid Valve ReplacementDevice

    Also called Edwards EVOQUE Tricuspid Valve Replacement System

    Replacement of the tricuspid valve through a transcatheter approach

Study groups in NCT04221490
Study groupRoleWhat they receive
TreatmentExperimentalTreatment with the Edwards EVOQUE Tricuspid Valve Replacement System
Receives: Device: Transcatheter Tricuspid Valve Replacement

What is being measured

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

  1. Composite Major Adverse Events (MAEs)

    Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days.

    Measured: 30 Days

  2. Device Success

    Study device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.

    Measured: Intraprocedural

  3. Procedure Success

    Device success without clinically significant paravalvular leak (PVL) on a transthoracic echocardiogram (assessed by the echo core lab) at time of discharge.

    Measured: Discharge (Up to 7 days post procedure)

  4. Clinical Success

    Procedural success without MAEs at 30 days.

    Measured: 30 Days

  5. Tricuspid Regurgitation Reduction

    Percentage of patients with at least 1 grade reduction in tricuspid regurgitation (TR) as measured by using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.

    Measured: Discharge (Up to 7 days post procedure)

Secondary outcomes (10)

  1. Tricuspid Regurgitation (TR) Grade

    Tricuspid regurgitation (TR) is measured by transthoracic echocardiogram (TTE) at each visit using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.

    Measured: Baseline, 30 Days, 6 Months

  2. New York Heart Association (NYHA) Functional Class

    NYHA Functional Classification - The stages of heart failure:

    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.

    Class IV - Severe limitations. Experiences symptoms even while at rest.

    Measured: Baseline, 30 Days, 6 Months

  3. Change in Six Minute Walk Test (6WMT) Distance

    Mean distance in meters walked during Six Minute Walk Test (6MWT) at each follow-up visit compared to baseline. 6MWT is a submaximal exercise test that measures the distance that a patient can walk on a flat surface in a period of 6 minutes.

    Measured: 30 Days, 6 Months

  4. Change in Quality of Life Score as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Mean KCCQ score at each follow-up visit compared to baseline. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.

    Measured: 30 Days, 6 Months

  5. Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Mental Score

    Mean change in SF-36 mental score at each follow-up visit compared to baseline compared to baseline. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

    Measured: 30 Days, 6 Months

  6. Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Physical Score

    Mean change in SF-36 physical score at each follow-up visit compared to baseline. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

    Measured: 30 Days, 6 Months

  7. Change in Body Weight

    Mean change in body weight in kilograms at each follow-up visit compared to baseline.

    Measured: 30 Days, 6 Months

  8. Change in Left Ankle Circumference

    Mean change in left ankle circumference in centimeters at each follow-up visit compared to baseline.

    Measured: 30 Days, 6 Months

  9. Change in Right Ankle Circumference

    Mean change in right ankle circumference in centimeters at each follow-up visit compared to baseline.

    Measured: 30 Days, 6 Months

  10. Edema Assessment By Visit

    The edema grading scale measures how quickly the dimple goes back to normal (rebound) after a pitting test. The scale includes:

    Grade 1: Immediate rebound with 0 to 2 millimeter (mm) pit. Grade 2: Less than 15-second rebound with 3 to 4 mm pit. Grade 3: Rebound greater than 15 seconds but less than 60 seconds with 5 to 6 mm pit.

    Grade 4: Rebound between 2 to 3 minutes with an 8 mm pit.

    Measured: Baseline, 30 Days, 6 Months

Timeline

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

  1. First posted9 Jan 2020
  2. Study start6 May 2020
  3. Primary completion5 Jan 2024
  4. Study completion31 Jan 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04221490
Sponsor's protocol ID
2019-06
Status last verified
Apr 2026
First submitted
6 Jan 2020
Last updated
8 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Kodali S, Hahn RT, Makkar R, Makar M, Davidson CJ, Puthumana JJ, Zahr F, Chadderdon S, Fam N, Ong G, Yadav P, Thourani V, Vannan MA, O'Neill WW, Wang DD, Tchetche D, Dumonteil N, Bonfils L, Lepage L, Smith R, Grayburn PA, Sharma RP, Haeffele C, Babaliaros V, Gleason PT, Elmariah S, Inglessis-Azuaje I, Passeri J, Herrmann HC, Silvestry FE, Lim S, Fowler D, Webb JG, Moss R, Modine T, Lafitte S, Latib A, Ho E, Goldberg Y, Shah P, Nyman C, Rodes-Cabau J, Bedard E, Brugger N, Sannino A, Mack MJ, Leon MB, Windecker S; the TRISCEND study investigators. Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study. Eur Heart J. 2023 Dec 7;44(46):4862-4873. doi: 10.1093/eurheartj/ehad667.

    PubMed 37930776

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter Tricuspid Valve Replacement in people with Tricuspid Valve Regurgitation and Heart Valve Diseases, run by Edwards Lifesciences at 20 sites in 4 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 3 inclusion and 5 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada, France, Switzerland. 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 9 Jan 2025). 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?

Composite Major Adverse Events (MAEs) (time frame: 30 Days). The study lists 5 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 NCT04221490, which also lists 2 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 8 May 2026.

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