Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Edwards Lifesciences

Status: Enrolling

Conditions: Degenerative Mitral Valve Disease; Functional Mitral Regurgitation; Mitral Insufficiency; Mitral Regurgitation

Treatments: Device: Edwards PASCAL System; Device: Abbott Mitraclip System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03706833

2018-07

Details and patient eligibility

About

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)

Full 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.

Enrollment: 1,247 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,247 participants in 5 patient groups

Edwards PASCAL System - CLASP IID

Experimental group

Description:

Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation

Treatment:

Device: Edwards PASCAL System

Abbott Mitraclip System - CLASP IID

Active Comparator group

Description:

Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation

Treatment:

Device: Abbott Mitraclip System

Edwards PASCAL System - CLASP IIF

Experimental group

Description:

Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation

Treatment:

Device: Edwards PASCAL System

Abbott Mitraclip System - CLASP IIF

Active Comparator group

Description:

Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation

Treatment:

Device: Abbott Mitraclip System

Edwards PASCAL System - Single-Arm Registry

Experimental group

Description:

Transcatheter mitral valve repair with the Edwards PASCAL System in patients with mitral regurgitation who were deemed non-randomizable by a central screening committee (CSC) due to complex anatomical features described in the current MitraClip Instructions for Use (IFU) but were considered suitable for the PASCAL system.

Treatment:

Device: Edwards PASCAL System