Active — Not RecruitingNot Applicable

TRISCEND II Pivotal Trial

United States864 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 range18 Years

SexALL

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: 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

Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

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 range18 Years

SexALL

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

Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Timeframe: 6 months