WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

Study Overview
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Brief Summary
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To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR).

Detailed Description
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WATCH-TAVR is a prospective, multicenter, randomized controlled trial. Only centers with approval for commercial WATCHMAN implantation will be included in this trial. Subjects will be enrolled at up to 32 centers in the United States. There will be up to 350 subjects enrolled, with 175 patients randomized to TAVR + medical therapy and 175 patients randomized to simultaneous TAVR+WATCHMAN to accumulate the necessary 191 primary events. Enrollment is expected to occur over the course of 18 months. Patients will be followed for a total of 2 years. Patients with non-valvular AF undergoing standard of care commercial TAVR will be enrolled in the trial. For patients who receive the WATCHMAN device, plan of care will follow WATCHMAN labeling.Patients randomized to receive the WATCHMAN device will receive anticoagulation with warfarin and aspirin for 6 weeks after the procedure. After 6 weeks, the plan of care will follow WATCHMAN labeling. Patients randomized to the TAVR + medical therapy arm will be treated in accordance with standard of care with either warfarin, other anticoagulant/antiplatelet therapy, or no anticoagulation at the discretion of the treating physician. All patients will continue to receive routine post-TAVR follow-up and care.Patients will be monitored for primary and secondary endpoints as outlined. Baseline information and laboratory data will be collected as described in the protocol.

Official Title
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WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

Conditions
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Atrial Fibrillation, Aortic Valve Stenosis

Intervention / Treatment
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* Device: WATCHMAN
* Device: TAVR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women ≥ 18 years of age. The patient meets criteria for and is scheduled to undergo TAVR procedure The patient has documented paroxysmal, persistent, or permanent atrial fibrillation. The patient meets the WATCHMAN labeling guidelines and is eligible to undergo the WATCHMAN implantation procedure. The patient is eligible for short term warfarin therapy. The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial. The patient is able and willing to return for required follow-up visits and examinations. Exclusion Criteria: The patient had a stroke or TIA within the last 6 months prior to enrollment. Contraindication for short term anticoagulation. 3 .Moderate or severe Mitral Stenosis with mean gradient across Mitral Valve >10 mm Hg or Mitral Valve Area < 1.2cm2. 4. The patient has symptomatic carotid disease (i.e.,carotid stenosis ≥ 50% associated with ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months). 5. Prior occlusion of LAA. 6. The patient has an implanted mechanical mitral valve. 7. The patient requires long-term warfarin therapy due to: Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months The patient is in a hypercoaguable state; exclude the patient if per medical record documentation, the patient meets any of the following criteria: Thrombosis occurring ≤ 40 years of age Idiopathic or recurrent VTE (venous thrombo-embolism) Thrombosis at an unusual site (cerebral veins, hepatic veins, renal veins, IVC, mesenteric veins) Family history of VTE or of inherited prothrombotic disorder, recurrence/extension of thrombosis while adequately anticoagulated. 8. The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable). 9. The patient is pregnant or pregnancy is planned during the course of the investigation if patient is of child bearing potential. 10. Any clinically significant medical condition or presence of any laboratory abnormality prior to randomization that is considered by the investigator to be clinically important and could interfere with the conduct of the study or not meeting procedure guidelines for TAVR or WATCHMAN. 11. The patient has a life expectancy of less than two years.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized in a 1:1 allocation ratio to the following treatment arms TAVR + Medical Therapy (n=175) or simultaneous TAVR + WATCHMAN (n=175)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAVR + Medical Therapy<br>n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation | Device: TAVR<br>* Transcatheter Aortic Valve Replacement<br>|
| Experimental: TAVR + WATCHMAN<br>n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device. | Device: WATCHMAN<br>* WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.<br>Device: TAVR<br>* Transcatheter Aortic Valve Replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all-cause mortality, stroke and bleeding | First occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 1 year | Through 1 year post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All deaths through 1 year | Through 1 year post-randomization | 
| Stroke | First occurrence of any ischemic or hemorrhagic stroke through 1 year | Through 1 year post-randomization | 
| Bleeding | First occurrence of any life-threatening or major bleeding through 1 year | Through 1 year post-randomization |