AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation: The APAF-CSP All-cause Mortality and Quality of Life Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 292
- 试验地点
- 23
研究概览
简要总结
The goal of this clinical trial is to learn if conduction system pacing works as well as cardiac resynchronization therapy (CRT) post atrioventricular (AV) node ablation in adult patients with symptomatic heart failure and atrial fibrillation that is not suitable for rhythm control.
The main question it aims to answer is:
Is AV node ablation with conduction system pacing noninferior to AV node ablation with CRT for the hierarchical composite outcome of all-cause mortality, heart failure hospitalization or urgent heart failure visit, and meaningful improvement in heart failure-related quality of life?
Participants will undergo:
- An AV node ablation and be randomly assigned to receive either a conduction system pacing or a CRT.
- Attend follow-up visits (in clinic or by telephone) at baseline, intervention day, 3-month, 12-month, 24-month, and 36-month after the procedure.
- Complete questionnaires about heart failure symptoms and quality of life at baseline, 12 months, and yearly.
- Have an echocardiogram, an electrocardiogram, and blood tests at baseline and 1 year
- At selected centers: they will be asked to wear a bracelet that measures arterial stiffness for 30 minutes and provide a urine sample at baseline and 1 year.
详细描述
- Study Rationale:
Therapeutic options for patients with symptomatic HF and AF that is not suitable for rhythm control are limited to pharmacological rate control and/or AV node ablation plus CRT implantation (Class IIa, Level of Evidence B). CSP is gaining more and more attention, and it has the advantage of utilizing the native conduction system to activate both ventricles simultaneously. This would achieve more physiologically synchronized ventricular contraction and circulation dynamics. We hypothesize that conduction system pacing would be as efficient as CRT pacing in patients with symptomatic heart failure and AF that is not suitable for rhythm control who are receiving the "ablate and pace" treatment strategy.
+Objective:
- Primary Objective:
To compare AV node ablation with conduction system pacing versus AV node ablation with cardiac resynchronization therapy (CRT) among the trial population with respect to the hierarchical composite endpoint of all-cause mortality, HF hospitalization or unplanned/urgent HF visit, and ≥5 point improvement (increase) in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score. 2. Secondary Objectives:
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 or above.
- •Patient is diagnosed with AF and deemed not amenable to rhythm control. This diagnosis of AF will be demonstrated by at least one Electrocardiograph (ECG) showing AF that was performed within one year prior to enrollment.
- •Has history of stable heart failure (regardless left ventricular ejection fraction) and has a history of at least one HF related hospitalization or emergency room/urgent care visit within 2 years prior to enrollment, despite being on maximally tolerable guideline directed medical therapy.
- •Willing and capable to provide informed consent.
排除标准
- •NYHA functional class IV.
- •Severe concomitant non-cardiac disease.
- •Patient who require any cardiac surgical intervention.
- •Previously implanted pacing devices (pacemaker/ICD/CRT) with ≥40% pacing burden.
- •Any of the following within the 3 months prior to enrollment:
- •Myocardial infarction
- •Unstable angina
- •Percutaneous coronary intervention
- •Stroke or TIA
- •Significant bleeding
- •Pericarditis/effusions
- •Coronary artery bypass surgery/atriotomy within 6 months prior to enrolment.
- •Women who are pregnant or breastfeeding.
研究者
M. Rienstra
MD, PhD, MHA, Professor of Clinical Cardiology
University Medical Center Groningen