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

NCT04494347 | Completed DMC

• 1 other identifier: 19-010047
• Study Type: observational
• Target: 25
• Locations: 2 countries
• Sites: 2

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 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.

Conditions

Nonvalvular Atrial Fibrillation; Severe Degenerative Mitral Regurgitation

Outcome Measures

Primary Outcomes (4)

• All-cause mortality rate

  Total number of Subject's Death

  45 days post procedure

• All-cause mortality rate

  Total number of Subject's Death

  1 Year post procedure

• Serious Adverse Events (SAEs)

  Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.

  45 days post procedure

• Serious Adverse Events (SAEs)

  Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.

  1 Year post procedure

Secondary Outcomes (1)

• SAEs related to the Study devices

  1 Year

Study Arms (1)

Treatment Group

This is not a randomized study. Patients who are clinically indicated for both procedures will be offered the option to enroll in this registry for a combined procedure. Otherwise, they will undergo TMVr and LAAO in two separate session as clinically indicated (standard of care).

Procedure: MitraClip TMVR and Watchman LAAO

Interventions

MitraClip TMVR and Watchman LAAO PROCEDURE

The MitraClip device is a percutaneous edge-to-edge repair device that is intended to approximate the anterior and posterior mitral valve leaflets in patients with severe symptomatic mitral regurgitation with suitable anatomy. Device versions/types: MitraClip NTr, MitraClip XTr. The WATCHMAN device is a self-expanding left atrial appendage occlusion (LAAO) device with a porous covering on the proximal face. Device sizes: 21 mm, 24 mm, 27 mm, 30 mm, 33 mm.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe symptomatic mitral regurgitation undergoing clinically indicated TMVr with the FDA approved MitraClip device, who also have an FDA indication for percutaneous left atrial appendage occlusion with the Watchman FLX device (atrial fibrillation + indication for long-term anticoagulation + rational to seek alternative to anticoagulation)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Study Officials

• Mohamad Adnan (Mohamad) Alkhouli, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 45 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 31, 2020
• Study Start: November 1, 2020
• Primary Completion: March 7, 2025
• Study Completion: March 7, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)