Ablation wiTh TRAnsCatheter Edge-to-edge Repair Versus ablaTION Alone for Atrial Functional Mitral Regurgitation and Atrial Fibrillation (ATTRACTION Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 384
- 主要终点
- Hierarchical Composite Clinical Endpoint (Win Ratio)
研究概览
简要总结
This trial is a randomized study for patients with significant atrial functional mitral regurgitation (AFMR) and atrial fibrillation (AF). The composite endpoint of all-cause mortality, cardiovascular-related hospitalizations, AF recurrence, and quality of life improvement is hypothesized to be superior with the combination of transcatheter edge-to-edge repair (TEER) and catheter ablation, compared with catheter ablation alone.
详细描述
Rationale:
The introduction of transcatheter edge-to-edge repair (TEER) for the treatment of functional mitral regurgitation (FMR) has led to a significant reduction in mortality and heart failure hospitalizations. However, the optimal timing and intervention for patients with atrial functional mitral regurgitation (AFMR) have not been evaluated in clinical trials. Published clinical trials, including COAPT, MITRA-FR, and RESHAPE-HF, did not classify functional mitral regurgitation according to ventricular or atrial origin. Concerns regarding the role of atrial fibrillation (AF) as a potential trigger of atrial dilatation and a consequence of atrial remodeling have led to recommendations for rhythm control in selected patients. Given the high incidence of AFMR among patients with persistent AF, successful ablation and maintenance of sinus rhythm may remain challenging. Therefore, concomitant TEER and catheter ablation are hypothesized to provide greater clinical benefit compared with catheter ablation alone.
Aim:
The purpose of this study is to evaluate the efficacy of TEER combined with catheter ablation in patients with significant AFMR and AF, focusing on clinical outcomes and atrial reverse remodeling.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 years
- •Left ventricular ejection fraction ≥ 50%
- •Grading of MR: 3+ or 4+ (effective regurgitant orifice area≥30mm2, regurgitant volume ≥45ml)
- •Valve morphology: MR originating from the mid portion of the valve; mitral valve area> 4 cm2; Length of posterior leaflet ≥10 mm; Sufficient leaflet tissue for mechanical coaptation: coaptation depth< 11 mm, coaptation length> 2 mm
- •Rate control in suspected AF-induced cardiomyopathy (heart rate <80 bpm at rest and <110 bpm during exercise)
- •Patients must be willing to comply with all follow-up requirements
排除标准
- •* Life expectancy\< 1 year due to non-cardiac conditions
- •* Primary mitral regurgitation: valve abnormalities including leaflet tethering from LV dysfunction, intrinsic leaflet pathology (prolapse, flail, calcification, severe thickening), mitral annular calcification (either severe or \ 70 mmHg
- •* Stroke/TIA, TAVR, CRT/ CRT-D/ ICD, cardiac intervention or surgery within 30 days before randomization
- •* Any prior MV surgery or transcatheter procedure
- •* Need for any cardiac surgery (other than for MV disease)
- •* Untreated clinically significant coronary artery disease
- •* Echocardiographic evidence of intracardiac thrombus
- •* Active infections requiring current antibiotic therapy
- •* Patients who cannot tolerate anti-platelet/anticoagulation agents/contrast media
- •* Pregnancy
- •* Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with medical therapy) and follow-up visits
- •* Patient (or legal guardian) unable or unwilling to provide written informed consent before study enrollment
结局指标
主要结局
Hierarchical Composite Clinical Endpoint (Win Ratio)
时间窗: 12 months
The primary endpoint is a single hierarchical composite clinical endpoint analyzed by pairwise comparison. Each participant in the transcatheter edge-to-edge repair (TEER) plus catheter ablation group is compared with each participant in the catheter ablation alone group, in order of clinical priority: all-cause mortality, cumulative cardiovascular-related hospitalization, atrial fibrillation recurrence, and change in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Each pairwise comparison is resolved at the highest-priority component that differs between the two participants, and results in a single "win," "loss," or "tie." The treatment effect is summarized as one win ratio, defined as the total number of wins divided by the total number of losses across all pairs, comparing the TEER plus catheter ablation group with the catheter ablation alone group.
次要结局
- Incidence of 30-day composite safety events(30 days)
- Change in mitral regurgitation grade from baseline(12 months)
- Composite of all-cause mortality and cardiovascular-related hospitalization(12 months)
- Cardiovascular mortality(12 months)
- Heart failure hospitalizations(12 months)
- Incidence of stroke or transient ischemic attack(12 months)
- Change in left atrial volume index(12 months)
- Change in left atrial reservoir function from baseline(12 months)
- Change in severity of tricuspid regurgitation from baseline(12 months)
- Change in NYHA functional classification from baseline(12 months)
- Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline(12 months)
研究者
Mao Chen
Director of Department of Cardiology
West China Hospital