Combining Watchman and MitraClip procedures for heart patients

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

This study is testing whether doing two heart procedures at once, using the Watchman and MitraClip devices, can safely help patients with certain heart issues avoid the risks of multiple surgeries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 2 sites (Rochester, Minnesota and 1 other locations)
• Trial ID: NCT04494347 on ClinicalTrials.gov

What this trial studies

The WATCH-TMVR trial aims to evaluate the feasibility of performing left atrial appendage closure using the Watchman device alongside transcatheter mitral valve repair with the MitraClip in a single session. This approach targets patients with nonvalvular atrial fibrillation and severe degenerative mitral regurgitation who are at high risk for traditional surgery. By combining these procedures, the trial seeks to minimize the risks associated with repeated access and anesthesia. The study will be coordinated by the Mayo Clinic and will involve multiple sites.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with severe symptomatic mitral regurgitation and documented atrial fibrillation who are eligible for anticoagulation therapy.

Not a fit: Patients with unsuitable mitral valve anatomy or contraindications for anticoagulation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the risks and complications associated with separate procedures for patients with both atrial fibrillation and severe mitral regurgitation.

How similar studies have performed: Limited case reports have shown safety and feasibility for combining these procedures, but this approach is still relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Men and Women ≥ 18 years of age;
2. The patient has severe symptomatic mitral regurgitation meet criteria for the commercially available MitraClip;
3. The patient also has documented paroxysmal, persistent, or permanent atrial fibrillation AND The patient meets the WATCHMAN labeling guidelines;
4. The patient is eligible for short-term oral anticoagulation therapy with Warfarin or a direct oral anticoagulant;
5. The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial;
6. The patient is able and willing to return for required follow-up visits.

Exclusion Criteria:

1. Mitral valve anatomy not deemed suitable for TMVr;
2. Moderate to severe mitral stenosis (mean gradient \>10 mmHg or MVA \<1.5 cm2);
3. Contraindication for short-term anticoagulation;
4. The patient has intra-cardiac thrombus as visualized by TEE within 1 week prior to Watchman procedure;
5. Prior occlusion of LAA;
6. Implanted mechanical mitral valve;
7. The patient requires long-term warfarin therapy due to:

   1. Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months.
   2. The patient is in a hypercoagulable state.
8. 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;
9. The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study and registries are acceptable);
10. The patient is pregnant, or pregnancy is planned during the course of the investigation if patient is of child bearing potential;
11. 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;
12. The patient has a life expectancy of less than one year.

Where this trial is running

Rochester, Minnesota and 1 other locations

• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Ottawa Heart Institute — Ottawa, Ontario, Canada (Active_not_recruiting)

Study contacts

• Principal investigator: Mohamad Adnan (Mohamad) Alkhouli, MD — Mayo Clinic
• Study coordinator: Mohamad Adnan (Mohamad) Alkhouli, MD

Conditions Nonvalvular Atrial Fibrillation; Severe Degenerative Mitral Regurgitation