United States, Canada, Germany1,247 participantsStarted 2018-11-30
Plain-language summary
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
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:
* Eighteen (18) years of age or older
* Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
* Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
* Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
* Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
* Mitral regurgitation (3+ to 4+) by echo
* Suitable valve and regurgitant jet morphology
* Elevated corrected BNP \> 400 pg/ml or corrected NT-pro BNP of \> 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)
* LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)
Exclusion Criteria:
* Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
* Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
* Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure)
* Clinically significant, untreated coronary artery disease
* Recent stroke
* Other severe valve disorders requiring intervention
* Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 mo…
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
1
PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs).
Timeframe: 30 days.
2
PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort.
Timeframe: 6 months
3
PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only.
Timeframe: From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up