Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04494347
Study type Interventional
Source Mayo Clinic
Contact Mohamad Adnan (Mohamad) Alkhouli, MD
Phone 507-255-2504
Email alkhouli.mohamad@mayo.edu
Status Recruiting
Phase N/A
Start date November 1, 2020
Completion date January 2026

See also
  Status Clinical Trial Phase
Recruiting NCT04586972 - Safety and Efficacy of Apixaban in Very Old Geriatric Subjects (> 80 Years) With Atrial FIbrillation in a Prospective reAl World Study;
Completed NCT02007655 - Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation
Completed NCT02674594 - Evaluation of Hospital Readmissions Among Hospitalized Non-valvular Atrial Fibrillation (NVAF) Patients in the US N/A
Not yet recruiting NCT04942873 - The Adherence to Oral Anticoagulant in Chinese Patients With NVAF
Recruiting NCT05731882 - First in Man Study of Left Atrial Appendage Pulsed Field Ablation Occluder N/A
Completed NCT01885598 - Eliquis Regulatory Post Marketing Surveillance N/A
Completed NCT02919982 - Benchmarking an Oral Anticoagulant Treatment Rate in Patients With Nonvalvular Atrial Fibrillation
Completed NCT00684307 - Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation Phase 2
Recruiting NCT04073316 - AntiCoagulants and COGnition Phase 4
Completed NCT03374540 - Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients
Recruiting NCT05715658 - Pharmacokinetic Study to Evaluate Dabigatran Etexilate in Elderly Subjects N/A