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

Download Trial Brochure

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

Heart Icon

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

The Edwards PASCAL Transcatheter Valve Repair System

The PASCAL Implant

  • Central spacer intended to fill the regurgitant orifice area
  • Spacer and broad, contoured paddle design reduce stress on leaflets
  • Clasps allow for independent leaflet capture and the ability to fine-tune leaflet position
The Pascal Implant

See how it works

Watch the PASCAL repair system procedural animation

CLASP IIF Trial Design

Investigation Device Group Investigation Device Group
Edwards PASCAL System
Edwards PASCAL System Edwards PASCAL System
Control Group Control Group
Edwards PASCAL System
MitraClip System MitraClip System

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).

Screening & Eligibility

(for both PASCAL system and MitralClip system)

1:1 Randomization
PASCAL System + GDMT

(N=225)

MitralClip System + GDMT

(N=225)

Eligibility and Enrollment Criteria

Key Inclusion Criteria1

  • Patient has 3+ or 4+ mitral regurgitation, as determined by echo
  • Patient is determined by the Heart Team to be a candidate for transcatheter mitral valve repair for both PASCAL and MitraClip
  • Patient is determined to be at prohibitive risk for mitral valve surgery by a Heart Team

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

Patient Selection
Screening & Enrollment

Patient Selection Screening & Enrollment

Heart Team

The Heart Team Approach for The CLASP IIF Cohort

The Heart Team is composed of a multidisciplinary, collaborative group of physicians and caregivers who take a rigorous approach to patient care in this trial to ensure appropriate patient selection and maximize outcomes.4

Patient Screening Process

Submit Assessments/Images via Cloud to Central Screening Committee

Guideline Directed Medical Therapy (GDMT) Verification

Internal/Core Lab Review

Baseline Screening Assessment/Images

Central Screening Committee Review

Submit Assessments/Images via Cloud to Central Screening Committee

Case Scheduling

Internal/Core Lab Review

Randomization

Central Screening Committee Review

Randomization

Case Scheduling

Patient Follow up1:

Patient follow up timeline
For more information

For more information

For more details related to the CLASP IID/IIF trial or to find a site near you, please visit: www.clinicaltrials.gov Search: NCT03706833

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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