Back to Results

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Primary Objective

The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip System in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team.

Study

Is this Study for You?

Let's Get Started!

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)

Details
Age

Adult

Eligibility

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)

Detailed Eligibility: 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. biventricular pacemakers, 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 (except surgical annuloplasty) or transcatheter mitral valve procedure Active rheumatic heart disease or rheumatic etiology for MR Severe aortic stenosis or regurgitation Known history of severe symptomatic 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

Phase

Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
John Carroll,  MD

John Carroll, MD

Study ID

Protocol Number: 18-2298

ClinicalTrials.gov: NCT03706833

Is this Study for You?

Let's Get Started!

Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers