Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- All-cause mortality rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: MitraClip TMVR and Watchman LAAO (Procedure)
结局指标
主要结局
All-cause mortality rate
时间窗: 1 Year post procedure
Total number of Subject's Death
Serious Adverse Events (SAEs)
时间窗: 1 Year post procedure
Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.
All-cause mortality rate
时间窗: 45 days post procedure
Total number of Subject's Death
Serious Adverse Events (SAEs)
时间窗: 45 days post procedure
Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.
次要结局
- SAEs related to the Study devices(1 Year)
研究者
Mohamad Adnan Alkhouli
Principal Investigator
Mayo Clinic