Active — Not RecruitingNot Applicable

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

United States1,247 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 range18 Years

SexALL

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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…

What they're measuring

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.

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

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

Trial details

NCT IDNCT03706833

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Degenerative Mitral Valve Disease trials