Active — Not RecruitingNot Applicable

TRISCEND II Pivotal Trial

United States, Germany864 participantsStarted 2021-04-09

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. PASP \>60 mmHg by echo Doppler (unless RHC demonstrates PASP ≤70 mmHg)
. PASP \>70 mmHg by RHC
. PVR \>5 Wood units by RHC (unless PVR ≤5 Wood units and systolic BP \>85 mmHg after vasodilator challenge)
. 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
. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days
. Carotid surgery within the last 30 days

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction

Timeframe: 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

Timeframe: 6 months

Randomized Cohort: Rate of Major Adverse Events (MAE)

Timeframe: 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

Timeframe: 1 year

Continued Access Study: Rate of Major Adverse Events (MAE)

Timeframe: 30 days

Continued Access Study: Tricuspid Regurgitation (TR) grade reduction to moderate, mild, or none/trace

Timeframe: 6 months

Trial details

NCT IDNCT04482062

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-05

View on ClinicalTrials.gov More Tricuspid Valve Regurgitation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. PASP \>60 mmHg by echo Doppler (unless RHC demonstrates PASP ≤70 mmHg)
. PASP \>70 mmHg by RHC
. PVR \>5 Wood units by RHC (unless PVR ≤5 Wood units and systolic BP \>85 mmHg after vasodilator challenge)
. 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
. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days
. Carotid surgery within the last 30 days

What they're measuring

Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction

Timeframe: 6 months

Randomized Cohort: Rate of Major Adverse Events (MAE)

Timeframe: 30 days

Timeframe: 1 year

Continued Access Study: Rate of Major Adverse Events (MAE)

Timeframe: 30 days

Continued Access Study: Tricuspid Regurgitation (TR) grade reduction to moderate, mild, or none/trace

Timeframe: 6 months