RECRUITING

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

Conditions

Nonvalvular Atrial Fibrillation Severe Degenerative Mitral Regurgitation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-11-01

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04494347

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Mohamad Adnan (Mohamad) Alkhouli, MD

CONTACT

507-255-2504

alkhouli.mohamad@mayo.edu

Principal Investigator

Mohamad Adnan (Mohamad) Alkhouli, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Mohamad Adnan (Mohamad) Alkhouli, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-01

Study Completion Date2026-01

Study Record Updates

Study Start Date2020-11-01

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Nonvalvular Atrial Fibrillation
Severe Degenerative Mitral Regurgitation