Edwards PASCAL CLASP IID Pivotal Clinical Trial

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and
effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter
Mitral Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral
regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve
surgery by the Heart Team.

Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually
through 5 years.

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.

- 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

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

- End-stage Heart Failure with inotrope support or consideration for LVAD or heart
transplant

- 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

- 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