NCT03173534

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

WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: samir kapadia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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. At trial conclusion, total number of subjects enrolled was 349. There were 172 subjects enrolled in the TAVR + Medical Therapy arm and 177 subjects enrolled in the TAVR + WATCHMAN arm.

Conditions

• Atrial Fibrillation
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	WATCHMAN	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.
DEVICE	TAVR	Transcatheter Aortic Valve Replacement

Timeline

• Start date: 2017-12-15
• Primary completion: 2022-12-06
• Completion: 2022-12-06
• First posted: 2017-06-02
• Last updated: 2024-05-22
• Results posted: 2024-05-22

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated device study