Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

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 corrected BNP > 400 pg/ml or corrected NT-pro BNP of > 900 pg/ml or heart
   failure hospitalization within the past 12 months (CLASP IIF cohort only)

   - LVEF ≥ 20% (and ≤ 50%; 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. left
   ventricular assist device, Status ≤5 heart 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 or transcatheter mitral valve procedure (excluding
   chordal replacement or surgical annuloplasty repair)

   - Severe tricuspid regurgitation or tricuspid valve disease requiring surgery

   - Active rheumatic heart disease or rheumatic etiology for MR

   - Severe aortic stenosis or regurgitation

   - Known history of untreated, severe carotid stenosis

   - Recent 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