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Transcatheter valve repair for patients with severe mitral regurgitation

Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation

Not applicable Interventional Edwards Lifesciences · NCT03706833

This study is testing a new heart valve repair system to see if it helps people with severe mitral regurgitation who can't have regular surgery feel better compared to another treatment option.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1247 (estimated)
Ages18 Years and up
SexAll
SponsorEdwards Lifesciences Industry-sponsored
Locations103 sites (Birmingham, Alabama and 102 other locations)
Trial IDNCT03706833 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation who are at high risk for traditional surgery, as well as in patients with functional mitral regurgitation receiving guideline-directed medical therapy. It is a multicenter, randomized, controlled trial comparing the PASCAL system to the Abbott MitraClip. Participants will undergo follow-up visits at discharge, 30 days, 6 months, and annually for up to five years to assess outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with severe mitral regurgitation who are at prohibitive risk for surgery or those on stable heart failure medications.

Not a fit: Patients who are not suitable candidates for transcatheter mitral valve repair or have contraindications for transesophageal echocardiography may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with severe mitral regurgitation who are not candidates for surgery.

How similar studies have performed: Other studies have shown success with similar transcatheter approaches for mitral valve repair, indicating a promising avenue for treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 months
* Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
* Severe tricuspid regurgitation or tricuspid valve disease requiring surgery
* Active rheumatic heart disease or rheumatic etiology for MR
* Severe aortic stenosis or regurgitation
* Known history of untreated, severe carotid stenosis
* Recent deep vein thrombosis (DVT) or pulmonary embolism (PE)
* Severe COPD
* Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
* Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
* Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment
* Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship

Where this trial is running

Birmingham, Alabama and 102 other locations

+53 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Degenerative Mitral Valve DiseaseMitral RegurgitationMitral InsufficiencyFunctional Mitral Regurgitation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.