A Study to Assess the Feasibility of Combining Clinically- indicated MitraClip Transcatheter Mitral Valve Repair (TMVR) and Watchman Left Atrial Appendage Occlusion (LAAO)
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-007047
About this study
This investigation constitutes a feasibility study involving assessing the safety and feasibility of combining clinically indicated Left Atrial Appendage Occlusion (LAAO) and Transcatheter Mitral Valve Repair (TMVR) in one setting using approved devices.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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 visit.
Exclusion Criteria:
- Mitral valve anatomy not deemed suitable for TMVr.
- Moderate to severe mitral stenosis (mean gradient >10 mmHg or MVA <1.5 cm^2).
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available