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 theheart 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 theheart 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 heartfailure 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, useand/or deployment or sufficient reduction in mitral regurgitation

• Patient with refractory heart failure requiring advanced intervention (i.e. leftventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heartfailure)

• 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 surgerywithin the next 12 months

• Any prior mitral valve surgery or transcatheter mitral valve procedure (excludingchordal 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 ofchildbearing potential need to have a negative pregnancy test performed within 14days 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 thejudgment of the Investigator

• Patient is currently participating in another investigational biologic, drug ordevice clinical study where the primary study endpoint was not reached at time ofenrollment

• Other medical, social, or psychological conditions that preclude appropriate consentand follow-up, including patients under guardianship