About This Trial
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 with Abbott MitraClip in patients with degenerative mitral regurgitation.1
What is Mitral Valve Regurgitation?
Mitral regurgitation (MR) (also referred to as “leaky valve”) is a malfunction causing blood to flow backwards from the left ventricle (LV) into the left atrium during ventricular systole. If MR is significant, blood can't move through the heart and to the body efficiently. When the valve leaks backwards it causes the heart to work harder which potentially gets worse over time, causing shortness of breath and other symptoms.2
Functional Mitral Regurgitation (FMR)
Functional mitral regurgitation (also know as secondary MR) occurs when the mitral valve apparatus is normal, and mitral regurgitation is attributed to a dilated left ventricle which causes papillary muscle displacement, with consequent annular dilatation that prevents the mitral valve leaflets from coapting normally.3
The Edwards PASCAL Transcatheter Valve Repair System
CLASP IIF Trial Design
The CLASP IIF Cohort Purpose1
The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System + GDMT compared with the MitraClip System + GDMT for the treatment of moderate-to-severe (3+) or severe (4+) FMR in symptomatic heart failure patients.
These patients have been determined by the site’s local multidisciplinary Heart Team to be eligible for transcatheter mitral valve repair.
Both the investigational device group and the control group will receive a minimally invasive treatment, either with the currently approved device or the investigational device.
The CLASP IIF Cohort Design
Patients will be randomized 1:1 to either treatment with the Edwards PASCAL System + GDMT (Device Group) or MitraClip System + GDMT (Control Group).
Eligibility and Enrollment Criteria
Key Inclusion Criteria1
Key Exclusion Criteria1
- 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 (ie, left ventricular assist device, transplantation, ACC/AHA Stage D heart failure)
- Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
- 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
Screening & Enrollment
Patient Screening Process
Patient Follow up1:
References: 1. Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial. 2. Mitral Valve Regurgitation: Symptoms and Causes. Mayo Clinic: Mayo Clinic website. https://www.mayoclinic.org/diseases-conditions/mitral-valve-regurgitation/symptoms-causes/syc-20350178. Accessed May 21, 2020. 3. Apostolidou E, Maslow AD, Poppas A. Primary mitral valve regurgitation: Update and review. Glob Cardiol Sci Pract. 2017;2017(1):e201703. 4. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:e57-e185.
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