Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATC… (NCT04494347) | Clinical Trial Compass
CompletedNot Applicable
Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)
United States, Canada25 participantsStarted 2020-11-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and Women ≥ 18 years of age;
✓. The patient has severe symptomatic mitral regurgitation meet criteria for the commercially available MitraClip;
✓. The patient also has documented paroxysmal, persistent, or permanent atrial fibrillation AND The patient meets the WATCHMAN labeling guidelines;
✓. The patient is eligible for short-term oral anticoagulation therapy with Warfarin or a direct oral anticoagulant;
✓. 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.
Exclusion criteria
✕. Mitral valve anatomy not deemed suitable for TMVr;
✕. Moderate to severe mitral stenosis (mean gradient \>10 mmHg or MVA \<1.5 cm2);
✕. Contraindication for short-term anticoagulation;
✕. The patient has intra-cardiac thrombus as visualized by TEE within 1 week prior to Watchman procedure;
✕. Prior occlusion of LAA;
✕. Implanted mechanical mitral valve;
✕. 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.