Ablation With Transcatheter Edge-to-edge Repair for Atrial Functional Mitral Regurgitation and Atrial Fibrillation (ATTRACTION)
2026年8月2日 更新者：Mao Chen
Ablation wiTh TRAnsCatheter Edge-to-edge Repair Versus ablaTION Alone for Atrial Functional Mitral Regurgitation and Atrial Fibrillation (ATTRACTION Study)
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.
研究概览
详细说明
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:
Patients with moderate-to-severe or severe AFMR and AF will be enrolled in a randomized, open-label, controlled study. Patients will be randomized in a 1:1 ratio to receive TEER combined with catheter ablation or catheter ablation alone. The study duration is anticipated to include 24 months of enrollment and 12 months of follow-up.
研究类型
介入性
注册 (估计的)
384
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zhengang Zhao
- 电话号码：86-18980733914
- 邮箱：zhaozhengang@foxmail.com
研究联系人备份
- 姓名：Lijun Zeng
- 电话号码：86-18810672833
- 邮箱：zenglijun2019@gmail.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 <severe but extending into the leaflets), and/or any mixed pathology
- Active endocarditis of the mitral valve or rheumatic mitral valve disease
- Hypotension (systolic pressure < 90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
- Severe tricuspid regurgitation; Physical evidence of right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction; Fixed pulmonary artery systolic pressure> 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：TEER+Ablation
Patients will undergo catheter ablation and transcatheter edge to edge repair.
|
Participants will undergo catheter ablation for persistent atrial fibrillation followed by transcatheter edge-to-edge repair (TEER) for the treatment of functional mitral regurgitation during the same hospitalization.
TEER will be performed using an approved transcatheter mitral valve repair system to reduce mitral regurgitation severity and improve cardiac function.
其他名称：
Participants will undergo catheter ablation for persistent atrial fibrillation during the study period.
The procedure will include pulmonary vein isolation with additional ablation strategies as clinically indicated.
|
|
有源比较器：Catheter ablation
Patients will undergo catheter ablation only.
|
Participants will undergo catheter ablation for persistent atrial fibrillation during the study period.
The procedure will include pulmonary vein isolation with additional ablation strategies as clinically indicated.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hierarchical Composite Clinical Endpoint (Win Ratio)
大体时间：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.
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of 30-day composite safety events
大体时间：30 days
|
The composite safety endpoint includes cardiovascular mortality, stroke, myocardial infarction, acute kidney injury, major bleeding, and non-elective cardiovascular surgery for device-related complications within 30 days after the procedure.
|
30 days
|
|
Change in mitral regurgitation grade from baseline
大体时间：12 months
|
Mitral regurgitation severity will be assessed by transthoracic echocardiography according to an integrated approach recommended by current guidelines.
The outcome will be the proportion of patients achieving mild or less mitral regurgitation (grade ≤2) at 12 months.
|
12 months
|
|
Composite of all-cause mortality and cardiovascular-related hospitalization
大体时间：12 months
|
The composite endpoint includes all-cause mortality and cardiovascular-related hospitalization within 12 months.
Death events will be identified through follow-up records, and cardiovascular-related hospitalizations will be confirmed by medical record review according to predefined criteria.
|
12 months
|
|
Cardiovascular mortality
大体时间：12 months
|
Cardiovascular mortality is defined as death caused by cardiovascular causes and will be determined through review of medical records and clinical documentation.
|
12 months
|
|
Heart failure hospitalizations
大体时间：12 months
|
Heart failure hospitalization is defined as an unplanned admission lasting ≥24 hours due to acute decompensated heart failure, with symptoms, signs, and/or laboratory evidence of heart failure and requiring intravenous or mechanical heart failure therapies.
Events will be identified through medical records and adjudicated according to predefined criteria.
|
12 months
|
|
Incidence of stroke or transient ischemic attack
大体时间：12 months
|
Stroke and transient ischemic attack events will be identified through clinical assessment, medical records, and neuroimaging findings.
Stroke will be classified as ischemic or hemorrhagic according to clinical diagnosis and imaging evaluation.
|
12 months
|
|
Change in left atrial volume index
大体时间：12 months
|
Left atrial volume index is assessed by the biplane method of disks and indexed to body surface area.
|
12 months
|
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Change in left atrial reservoir function from baseline
大体时间：12 months
|
Left atrial reservoir function will be assessed using speckle-tracking echocardiography, and the change from baseline to 12 months will be evaluated.
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12 months
|
|
Change in severity of tricuspid regurgitation from baseline
大体时间：12 months
|
Tricuspid regurgitation severity will be assessed by transthoracic echocardiography using an integrated approach according to current guidelines.
The change in tricuspid regurgitation severity from baseline to 12 months will be evaluated.
|
12 months
|
|
Change in NYHA functional classification from baseline
大体时间：12 months
|
The New York Heart Association (NYHA) functional class will be assessed by clinical evaluation based on patients' symptoms and limitations during physical activity.
The change from baseline to 12 months will be evaluated.
|
12 months
|
|
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline
大体时间：12 months
|
Plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels will be measured using standard laboratory assays.
The change from baseline to 12 months will be evaluated.
|
12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.
- Stone GW, Vahanian AS, Adams DH, Abraham WT, Borer JS, Bax JJ, Schofer J, Cutlip DE, Krucoff MW, Blackstone EH, Genereux P, Mack MJ, Siegel RJ, Grayburn PA, Enriquez-Sarano M, Lancellotti P, Filippatos G, Kappetein AP; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: A consensus document from the mitral valve academic research consortium. Eur Heart J. 2015 Aug 1;36(29):1851-77. doi: 10.1093/eurheartj/ehv281. Epub 2015 Jul 13.
- Wunderlich NC, Siegel RJ. Peri-interventional echo assessment for the MitraClip procedure. Eur Heart J Cardiovasc Imaging. 2013 Oct;14(10):935-49. doi: 10.1093/ehjci/jet060.
- Farhan S, Silbiger JJ, Halperin JL, Zhang L, Dukkipati SR, Vogel B, Kini A, Sharma S, Lerakis S. Pathophysiology, Echocardiographic Diagnosis, and Treatment of Atrial Functional Mitral Regurgitation: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Dec 13;80(24):2314-2330. doi: 10.1016/j.jacc.2022.09.046.
- Stone GW, Abraham WT, Lindenfeld J, Kar S, Grayburn PA, Lim DS, Mishell JM, Whisenant B, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Asch FM, Mack MJ; COAPT Investigators. Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. 2023 Jun 1;388(22):2037-2048. doi: 10.1056/NEJMoa2300213. Epub 2023 Mar 5.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2028年9月1日
研究完成 (估计的)
2029年9月1日
研究注册日期
首次提交
2026年7月18日
首先提交符合 QC 标准的
2026年8月2日
首次发布 (实际的)
2026年8月4日
研究记录更新
最后更新发布 (实际的)
2026年8月4日
上次提交的符合 QC 标准的更新
2026年8月2日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.