Optimizing Clinical Outcomes in Patients Undergoing M-TEER for Severe Functional Mitral Regurgitation Towards Improved Guideline-directed Medical Therapy - The MOTOR Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Rate of Heart Failure hospitalizations after mitral transcatheter edge-to-edge repair (M-TEER)
研究概览
简要总结
A multi-centre, prospective, observational pilot registry in patients undergoing mitral valve repair for severe functional mitral regurgitation to report the heart failure drug therapy and dosing before the mitral valve procedure and afterwards to assess whether the recommended maximal dose of medication is administered. This maximal dose, although recommended, might not be tolerated well by patients and can cause side-effects. Researchers will determine whether the mitral valve repair procedure might have a possible effect on increasing the drug therapy towards the recommended optimal doses.
详细描述
Mitral transcatheter edge-to-edge repair (M-TEER) has become an important therapy in the management of severe functional mitral regurgitation (FMR).
These patients often have left ventricular dilatation with associated left ventricular failure and undergo intervention after guideline-directed medical therapy (GDMT) is optimised.
However, many patients cannot tolerate maximal doses of these drugs, some of which are potent vasodilators, due to the potential for hypotension and other side effects.
After M-TEER, with significant reduction of valve regurgitation, and a consequent improvement in systemic blood pressure and left ventricular function, it may be possible to further optimize GDMT and thus improve patients' clinical outcomes.
This pilot registry will be conducted in up to 4 German centres with a minimum annual volume of ~ 50 M-TEER procedures aiming for an environment of 100 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •mitral transcatheter edge-to-edge repair (M-TEER) patients treated with the PASCAL system (≥ 18 years) as per the current approved indication and local Heart Team decision
- •Severe functional and mixed-type mitral regurgitation with LV-EF < 50%
- •Patient with optimized guideline-directed medical therapy (GDMT): A minimum of 3 points in the pre-defined GMDT scoring system
- •Provision of written informed consent
排除标准
- •Degenerative mitral regurgitation
- •Emergency procedure
- •Re-do or concomitant (mitral/tricuspid) procedures
- •Patients on maximum dose GDMT
- •Atrial functional mitral regurgitation (FMR)
- •Coronary revascularisation within the last 3 months
- •Pregnant woman
结局指标
主要结局
Rate of Heart Failure hospitalizations after mitral transcatheter edge-to-edge repair (M-TEER)
时间窗: 6 and 12 months
Number of 6- and 12-months heart failure (HF) hospitalizations post M-TEER procedure compared to 12- and 6-months historical HF hospitalization prior the index procedure
次要结局
- New York Heart Association (NYHA) class(6 months)
- 6-minute walk test(6 months)