Combining Watchman and MitraClip procedures for heart patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: alkhouli.mohamad@mayo.edu
• Phone: 507-255-2504

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TEE-Guided vs CCTA-Guided Preprocedural Imaging for Left Atrial Appendage Closure

  This trial tests whether using transesophageal echocardiography (TEE) or cardiac CT angiography (CCTA) for preprocedural planning helps people with nonvalvular atrial fibrillation who are getting a left atrial appendage closure determine the best device size and approach.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT07815119

• Apixaban safety and adherence in nonvalvular atrial fibrillation

  See if apixaban is safe and how well adults with nonvalvular atrial fibrillation stick to the medication over six months.

  Recruiting Bosnalijek D.D · Sarajevo · NCT07458191

• No blood-thinners versus aspirin after left atrial appendage closure

  This trial tests whether skipping antithrombotic drugs after left atrial appendage closure (using only 45 days of oral anticoagulant) is as safe and effective as taking aspirin for people with nonvalvular atrial fibrillation who are at high bleeding risk.

  Recruiting at 20 sites Phase 4 OCEAN-SHD Study Group · Nagoya, Aichi-ken and 20 other locations · NCT07125417

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.