Status:
RECRUITING
Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)
Lead Sponsor:
Mayo Clinic
Conditions:
Nonvalvular Atrial Fibrillation
Severe Degenerative Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Mit...
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 str...
Eligibility Criteria
Inclusion
- 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
- 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.
- The patient is in a hypercoagulable state.
- Exclude the patient if per medical record documentation the patient meets any of the following criteria: • Thrombosis occurring at under 40 years age • Idiopathic or recurrent VTE (venous thromboembolism • 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 anti-coagulated;
- The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study and registries are acceptable);
- The patient is pregnant, or pregnancy is planned during the course of the investigation if patient is of child bearing potential;
- Any clinically significant medical condition or presence of any laboratory abnormality performed 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 WATCHMAN or TMVr with MitraClip;
- The patient has a life expectancy of less than one year.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04494347
Start Date
November 1 2020
End Date
January 1 2026
Last Update
February 5 2025
Active Locations (2)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7