Clinical Trials

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 2/21/23. Questions regarding updates should be directed to the study team contact.