Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 33
- 主要终点
- All-cause mortality and non-fatal heart failure events
研究概览
简要总结
Cardiac resynchronization therapy (CRT) is a treatment for heart failure in patients who also suffer from ventricular dyssynchrony, a form of uncoordinated contraction of the ventricle (lower pumping chamber of the heart). In the past decade, CRT has become an established treatment for heart failure patients who are in normal rhythm, called sinus rhythm. An important subset of heart failure patients are those with atrial fibrillation (AF), who make up around 1 in 4 HF patients, and are over-represented amongst HF patients with more advanced symptoms. In heart failure patients with AF, CRT has proven not to be as effective as in sinus rhythm, due to competition between beats generated by the CRT device and beats conducted from the heart's own electrical conduction system. In the current study, we aim to test the hypothesis that ablating the AV node, which controls electrical conduction from the heart's atria (top chamber) to its ventricles (lower chambers), will improve survival and heart failure symptoms in CRT patients with co-existent AF. The results are important, because they will provide a way of passing on the benefits of CRT, such as improved survival, less heart failure symptoms, and better quality of life, to heart failure patients who also suffer from AF.
详细描述
Background: Cardiac Resynchronization Therapy (CRT) is an established treatment in heart failure (HF) patients with ventricular dyssynchrony who remain in sinus rhythm. Available clinical data has shown inferior outcomes of CRT in HF patients with co-existent atrial fibrillation (AF), who comprise up to 27% of HF patients, and are over-represented in advanced HF classes. We hypothesize, based on the results of a systematic review we recently published in the Journal of the American College of Cardiology, that AV nodal ablation may improve survival, heart failure and functional outcomes in CRT recipients with co-existent AF.
Design: This study will be a multicentre, prospective, randomized controlled trial. Patients with ischemic or nonischemic cardiomyopathy heart failure (NYHA II, III or ambulatory class IV), left ventricular dysfunction (EF ≤ 35%), prolonged intraventricular conduction (QRS duration ≥ 120ms), and persistent or permanent AF will be considered for the study. Persistent AF will be defined as patients where obtaining and maintaining sinus rhythm is deemed either not worthwhile, or to be ineffective in the long term, or where both the patient and the physician accept the presence of AF, where rhythm control intervention is, by definition, no longer pursued. Permanent AF is defined as AF where sinus rhythm cannot be restored.
Eligible subjects will be randomized into one of two arms: (1) CRT-D plus AV nodal ablation ("AV nodal ablation arm [AVNA]") or (2) CRT-D alone ("rate control arm").
Enrollment: 590 subjects, with 295 subjects in the AV node ablation arm and 295 subjects in the control arm, will be enrolled. Study patients will undergo stratified randomization at ≥ 30 days after CRT implant. Participants in will sign informed consent and be screened prior to randomisation. After CRT implant, patients will have at least 30 days for optimisation of heart failure therapy, prior to randomisation.
Randomisation: A computer-generated web-based randomisation schedule will be used. Randomisation will be stratified by trial centre. Randomisation is considered the trial entry point.
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 old
- •Persistent (≥ 1 month) or permanent atrial fibrillation. Persistent AF will be where obtaining and maintaining sinus rhythm is deemed either not worthwhile, or to be ineffective in the long term, or where both the patient and physician accept the presence of AF, where rhythm control intervention is, by definition no longer pursued. Permanent AF is defined as atrial fibrillation where sinus rhythm cannot be restored.
- •NYHA class II , III or ambulatory class IV heart failure
- •Left Ventricular Ejection Fraction (LVEF) ≤ 35% by objective criteria such as echocardiography, or cardiac MRI
- •QRS duration on 12-lead ECG ≥ 120ms
- •Able and willing to comply with all pre-, post- and follow-up testing and requirements.
排除标准
- •age < 18 years
- •pregnancy
- •previous AV nodal ablation
- •Second or third degree AV block
- •Inability to provide informed consent
- •life expectancy less than 24 months due to co-morbid illness other than heart failure erg cancer, end-stage renal disease, liver failure
- •Paroxysmal Atrial Fibrillation that self terminates within 7 days
研究组 & 干预措施
Medical Rate Control
Medical Rate Control aimed at ventricular rate target of 90 beats per minute. Specific medical therapy to be determined for each patient by individual clinician.
干预措施: Medical Ventricular Rate Control (Drug)
AV nodal ablation
AV node ablation performed by percutaneous catheter ablation, with endpoint of complete heart block.
干预措施: AV nodal ablation (Procedure)
结局指标
主要结局
All-cause mortality and non-fatal heart failure events
时间窗: Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)
This is a composite of all-cause mortality and non-fatal heart failure events. All-cause mortality will be determined by a designated clinical events committee. Heart Failure events will be documented by clinical data from the hospital In CAAN-AF, a subject will be described as having a "Heart Failure Event" when the subject has symptoms and/or signs consistent with congestive heart failure and: * responsive to parenteral diuretic or inotropic support as an outpatient * responsive to oral or parenteral diuretic or inotropic support during an inpatient stay
次要结局
- 6-minute walking distance(Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up))
- Quality of Life questionnaires(Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up))
- Unplanned Hospitalization(Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up))
- All-cause mortality(Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up)f recruitment)
- Cardiovascular mortality(Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up))
- Non-Fatal Heart Failure Events(Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up))
- Ventricular arrhythmias requiring device therapy(Final-analysis at completion of recruitment and follow-up period (minimum 2 year follow-up))
研究者
Prashanthan Sanders
Director, Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital
University of Adelaide