Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)

Inclusion Criteria:

1. Men and Women ≥ 18 years of age;

2. The patient has severe symptomatic mitral regurgitation meet criteria for thecommercially available MitraClip;

3. The patient also has documented paroxysmal, persistent, or permanent atrialfibrillation AND The patient meets the WATCHMAN labeling guidelines;

4. The patient is eligible for short-term oral anticoagulation therapy with Warfarin ora direct oral anticoagulant;

5. The patient or legal representative is able to understand and willing to providewritten informed consent to participate in the trial;

6. The patient is able and willing to return for required follow-up visits.

Exclusion Criteria:

1. Mitral valve anatomy not deemed suitable for TMVr;

2. Moderate to severe mitral stenosis (mean gradient >10 mmHg or MVA <1.5 cm2);

3. Contraindication for short-term anticoagulation;

4. The patient has intra-cardiac thrombus as visualized by TEE within 1 week prior toWatchman procedure;

5. Prior occlusion of LAA;

6. Implanted mechanical mitral valve;

7. The patient requires long-term warfarin therapy due to:

8. Secondary to conditions such as prior arterial embolism or other indicationssuch as pulmonary embolism or deep vein thrombosis within the previous 6months.

9. The patient is in a hypercoagulable state.

10. Exclude the patient if per medical record documentation the patient meets any of thefollowing criteria: • Thrombosis occurring at under 40 years age • Idiopathic orrecurrent VTE (venous thromboembolism • Thrombosis at an unusual site (cerebralveins, hepatic veins, renal veins, IVC, mesenteric veins) • Family history of VTE orof inherited prothrombotic disorder, recurrence/extension of thrombosis whileadequately anti-coagulated;

11. The patient is actively enrolled in another trial of a cardiovascular device or aninvestigational drug (post-market study and registries are acceptable);

12. The patient is pregnant, or pregnancy is planned during the course of theinvestigation if patient is of child bearing potential;

13. Any clinically significant medical condition or presence of any laboratoryabnormality performed prior to randomization that is considered by the investigatorto be clinically important and could interfere with the conduct of the study or notmeeting procedure guidelines for WATCHMAN or TMVr with MitraClip;

14. The patient has a life expectancy of less than one year.