Purpose

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)

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Edwards PASCAL System - CLASP IID
Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation
  • Device: Edwards PASCAL System
    Transcatheter mitral valve repair with the Edwards PASCAL System
    Other names:
    • Transcatheter Mitral Valve repair (TMVr)
Active Comparator
Abbott Mitraclip System - CLASP IID
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation
  • Device: Abbott Mitraclip System
    Transcatheter mitral valve repair with the Abbott Mitraclip System
    Other names:
    • Transcatheter Mitral Valve repair (TMVr)
Experimental
Edwards PASCAL System - CLASP IIF
Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation
  • Device: Edwards PASCAL System
    Transcatheter mitral valve repair with the Edwards PASCAL System
    Other names:
    • Transcatheter Mitral Valve repair (TMVr)
Active Comparator
Abbott Mitraclip System - CLASP IIF
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation
  • Device: Abbott Mitraclip System
    Transcatheter mitral valve repair with the Abbott Mitraclip System
    Other names:
    • Transcatheter Mitral Valve repair (TMVr)

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Edwards Lifesciences

Study Contact

Edwards TMTT Clinical Affairs
(949) 250-2500
TMTT_Clinical@edwards.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.