Nonvalvular Atrial Fibrillation, Severe Degenerative Mitral Regurgitation
Conditions
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.
Detailed description
Left atrial appendage closure using the Watchman device procedure is approved by the FDA for patients with nonvalvular atrial fibrillation who have an indication for oral anticoagulation to reduce stroke risk but who also have a rational to seek an alternative to long-term anticoagulation (e.g., recurrent bleeding, fall risk). Transcatheter mitral valve repair with the MitraClip device is approved by the FDA for patients with severe degenerative mitral regurgitation who are deemed to be at high-risk for valve surgery and patients with severe secondary MR despite optimal medical therapy. It is also anticipated that the device will soon be approved for patients with severe symptomatic functional mitral regurgitation based on the results of the COAPT trials. Atrial fibrillation is common in patients referred for TMVr. A recent study from the Mayo Clinic documented that up to 50% of patients undergoing TMVr might qualify for LAA based on their risk assessment. Both procedures are performed via a large bore femoral venous access, and utilize transseptal puncture, general anesthesia, and transesophageal echo guidance. Hence, combining the two procedures in one session might provide incremental benefit to those patients by avoiding the risk of repeated large-bore access, transseptal puncture, and general anesthesia. A limited number of case reports illustrated the safety and feasibility of a combined TMVr with LAAO when clinically indicated. Experience with combined TMVr/LAAO in the United States is limited, mostly due to the lack of supportive data and concerns about the incremental cost of the Watchman device that might not be covered by the Center for Medicare Services (CMS) per current guidelines.
Interventions
PROCEDUREMitraClip TMVR and Watchman LAAO
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.
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality rate | 45 days post procedure | Total number of Subject's Death |
| Serious Adverse Events (SAEs) | 45 days post procedure | Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SAEs related to the Study devices | 1 Year | Total number of the Subject's to experience SAEs as related to Watchman and the LAAO devices. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORMohamad Adnan (Mohamad) Alkhouli, MD
Mayo Clinic
Outcome results
None listed