Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial (CLASP IID/IIF)

  • STATUS
    Recruiting
  • End date
    Jan 31, 2028
  • participants needed
    1275
  • sponsor
    Edwards Lifesciences
Updated on 6 May 2022
medical therapy
regurgitation
heart failure
mitral valve repair
functional mitral regurgitation

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)

Description

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 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)

Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.

Details
Condition Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
Treatment Edwards PASCAL System, Abbott Mitraclip System
Clinical Study IdentifierNCT03706833
SponsorEdwards Lifesciences
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

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 BNP > 150 pg/ml or corrected NT-pro BNP of > 600 pg/ml or heart failure hospitalization within the past 12 months (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, 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)
Active rheumatic heart disease or rheumatic etiology for MR
Severe aortic stenosis or regurgitation
Known history of untreated, severe carotid stenosis
History of 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
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