Physiological Ventricular Pacing Versus Managed Ventricular Pacing for Persistent Atrial Fibrillation Prevention in Patients With Prolonged Atrioventricular Interval: a Multicenter RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- PeAF Free
研究概览
简要总结
A multicenter, prospective, randomized study in a 1:1 ratio, single-blind with double-blind evaluation to evaluate the superiority of physiological ventricular pacing (proposed modality) vs. managed ventricular pacing (control) for prevention of persistent AF (PeAF) occurrence in patients with prolonged atrioventricular interval (PR≥180 ms) and indication for pacing: sinus node disease and/or paroxysmal type 1 or 2-second degree AV block.
详细描述
Study aim: Evaluate the superiority of physiological ventricular pacing (proposed modality) vs. managed ventricular pacing (control) for prevention of persistent AF (PeAF) occurrence in patients with prolonged atrioventricular interval (PR≥180 ms) and indication for pacing: sinus node disease and/or paroxysmal type 1 or 2-second degree AV block. If the efficacy superiority is confirmed, this pacing mode may be considered to reduce the occurrence of persistent atrial fibrillation in this group of patients.
Study design: Independent, multicenter, prospective, randomized study in a 1:1 ratio, single-blind with double-blind evaluation (the actual evaluator of the primary endpoint is the pacemaker device's internal diagnostic algorithm, without intervention by the Investigator). This study will use only CE-marked devices already part of clinical practice.
Groups:
- PhysioVP group: the Physiological Ventricular Pacing is achieved by delivering a pacing stimulus to a cardiac conduction structure, such as the bundle of His or left bundle branch of the His-Purkinje system, with a permanent lead. PhysioVP activates the heart through the native His-Purkinje conduction system, thus offering the most physiologic pacing approach to correct the PR interval and avoiding pacing-induced dyssynchrony.
- DDD-VPA group: In managed ventricular pacing, the right ventricular (RV) lead is implanted in the myocardial right ventricular (septum or apex). In this pacing mode, the ventricular pacing is minimized by using algorithms for right Ventricular Pacing Avoidance.
Devices used:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
single-blind with double-blind evaluation (the actual evaluator of the primary endpoint is the pacemaker device's internal diagnostic algorithm, without intervention by the Investigator)
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
- •18 years older patients, able to express Informed Consent, with prolonged atrioventricular interval (PR>180 ms) and one of the following indications for PM implantation according to current guidelines:
- •Sinus node disease.
- •Paroxysmal type1or 2 second-degree AV-block.
排除标准
- •Candidacy for implantable cardioverter-defibrillator or cardiac resynchronization therapy device implantation.
- •Severe grade mitral or aortic regurgitation/stenosis.
- •Atrial fibrillation ablation (left pulmonary veins).
- •Cardiac surgery < 3 months before PM implantation.
- •History of long-standing persistent AF.
- •Permanent third-degree AV block.
- •Participation in another clinical trial in the past 3 months.
- •Pregnancy or intention to become pregnant.
- •Life expectancy of < 3 years.
结局指标
主要结局
PeAF Free
时间窗: 36 months
Freedom from persistent AF occurrences up to 36 months after the pacemaker (PM) implant. The occurrence of PeAF is defined as the first AF / Atrial Flutter / Atrial Tachycardia episode lasting \> 7 days, detected by the PM after a 1-month post PM lead-stabilization period. A day of AF is satisfied with a device-detected daily AF burden of ≥ 23 hours. Device-detected AF may also be collected by remote monitoring tools, if available. The definition also includes the occurrence of episodes terminated by cardioversion, whatever its duration or undergoing AF ablation
Clinical composite outcome
时间窗: 36 months
Composite outcome based on the occurrence of one or more of the events: Death from cardiovascular disease, or heart failure, or pacing system upgrading to the conduction system pacing (CSP) or to the biventricular pacing (BVP).
次要结局
- Hemodynamic performance, LV remodeling 1(12 months)
- Hemodynamic performance, LV remodeling 2(12 months)
- Hemodynamic performance, Diastolic function 2(12 months)
- Hemodynamic performance, Diastolic function 1(12 months)
- Hemodynamic performance, Diastolic function 3(12 months)
- Hemodynamic performance, Diastolic function 4(12 months)
- Hemodynamic performance, Diastolic function 5(12 months)
- Hemodynamic performance, Left atrial volume(12 months)
- Hemodynamic performance, Mitral regurgitation(12 months)
- Clinical evaluations, NYHA(12, 24, and 36 months)
- Clinical evaluations, MLHFQ(12, 24, and 36 months)
- Clinical evaluations(12, 24, and 36 months)
- Safety endpoints, PRAE(36 months)
- Safety endpoints, Potentially harmful factor 1(36 months)
- Safety endpoints, Potentially harmful factor 2(36 months)
- Safety endpoints, Incidence Rate of re-interventions(36 months)
- Estimated battery longevity(36 months)