NCT04494347

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

WATCH-TMVR (Watchman for Patients with Atrial Fibrillation Undergoing Transcatheter Mitral Valve) Clinical Trial have the main objective to assess the feasibility of combining clinically indicated MitraClip TMVR and Watchman LAAO in one setting.Mayo Clinic will be the data coordinating center for this trial, which will include up to 3 sites.

Detailed description

Left atrial appendage closure using the Watchman device procedure is approved by the FDA for patients with nonvalvular atrial fibrillation who have an indication for oral anticoagulation to reduce stroke risk but who also have a rational to seek an alternative to long-term anticoagulation (e.g., recurrent bleeding, fall risk). Transcatheter mitral valve repair with the MitraClip device is approved by the FDA for patients with severe degenerative mitral regurgitation who are deemed to be at high-risk for valve surgery and patients with severe secondary MR despite optimal medical therapy. It is also anticipated that the device will soon be approved for patients with severe symptomatic functional mitral regurgitation based on the results of the COAPT trials. Atrial fibrillation is common in patients referred for TMVr. A recent study from the Mayo Clinic documented that up to 50% of patients undergoing TMVr might qualify for LAA based on their risk assessment. Both procedures are performed via a large bore femoral venous access, and utilize transseptal puncture, general anesthesia, and transesophageal echo guidance. Hence, combining the two procedures in one session might provide incremental benefit to those patients by avoiding the risk of repeated large-bore access, transseptal puncture, and general anesthesia. A limited number of case reports illustrated the safety and feasibility of a combined TMVr with LAAO when clinically indicated. Experience with combined TMVr/LAAO in the United States is limited, mostly due to the lack of supportive data and concerns about the incremental cost of the Watchman device that might not be covered by the Center for Medicare Services (CMS) per current guidelines.

Conditions

• Nonvalvular Atrial Fibrillation
• Severe Degenerative Mitral Regurgitation

Interventions

Type	Name	Description
PROCEDURE	MitraClip TMVR and Watchman LAAO	The MitraClip device is a percutaneous edge-to-edge repair device that is intended to approximate the anterior and posterior mitral valve leaflets in patients with severe symptomatic mitral regurgitation with suitable anatomy. Device versions/types: MitraClip NTr, MitraClip XTr. The WATCHMAN device is a self-expanding left atrial appendage occlusion (LAAO) device with a porous covering on the proximal face. Device sizes: 21 mm, 24 mm, 27 mm, 30 mm, 33 mm.

Timeline

• Start date: 2020-11-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2020-07-31
• Last updated: 2025-02-05

Locations

2 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study