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

Who is this study for? Patients with atrial fibrillation undergoing transcatheter mitral valve repair
What treatments are being studied? MitraClip TMVR+Watchman LAAO
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Other Locations
Canada
Ottawa Heart Institute
ACTIVE_NOT_RECRUITING
Ottawa
Contact Information
Primary
Mohamad Adnan (Mohamad) Alkhouli, MD
alkhouli.mohamad@mayo.edu
507-255-2504
Time Frame
Start Date: 2020-11-01
Estimated Completion Date: 2026-01
Participants
Target number of participants: 25
Treatments
Experimental: 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).
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov