Active — Not RecruitingNot Applicable

Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System

Germany, Greece, Italy300 participantsStarted 2021-01-15

Plain-language summary

This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid valve repair.

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.

Inclusion criteria

. Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team
. TR grade ≥3+ (5 grade classification)
. Patient is eligible to receive the PASCAL device per the current approved indications for use

Exclusion criteria

. Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement
. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
. Any patient considered to be part of a vulnerable population

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

Number of patients with major adverse events (MAE rates)

Timeframe: 30 days

Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography

Timeframe: Discharge: defined as discharge or 7 days post-procedure, whichever comes first

Trial details

NCT IDNCT04614402

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-04-20

View on ClinicalTrials.gov More Tricuspid Valve Insufficiency trials