AtrioVentricular Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Number of patients developing pacemaker-induced cardiomyopathy
研究概览
简要总结
AVA CONDUCT is a prospective, multicenter, randomized study with single blinding, comparing left bundle branch area (LBBA) pacing with right ventricular (RV) pacing following AV node ablation in terms of clinical, functional, and electrophysiological outcomes.
The primary hypothesis is that pacing-induced cardiomyopathy, defined as a decrease in LVEF by 10% or more from baseline to an absolute value below 50%, occurs significantly more frequently in patients receiving RV pacing compared with LBBA pacing. Secondarily, LBBA pacing is expected to maintain comparable procedural safety while providing better cardiac function, resulting in improved quality of life and functional capacity compared with conventional RV pacing.
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
- Single (Participant)
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
- •History of symptomatic AF (EHRA IIb - IV) despite guideline-indicated medical or interventional therapy
- •Preserved LVEF (≥ 50%, assessed by echocardiography, Simpson's biplane method)
- •AV node ablation scheduled independently of possible study participation
- •Age ≥ 18 years
- •Consent capacity
排除标准
- •Impaired LVEF (< 50%)
- •Pre-implanted pacemaker
- •Contraindication for pacemaker implantation or AV node ablation (see chapter 5.3 for details)
- •High grade (III°) left cardiac valvular disease
- •Surgical coronary revascularization (within the last 30 days) or current triple therapy after stent PCI
- •Body-mass-index > 40 kg/m2
- •Inability to give written informed consent
- •Life expectancy < 12 months
研究组 & 干预措施
Right ventricular pacing
干预措施: RV pacing (Procedure)
Left bundle branch area pacing
干预措施: LBBA pacing (Procedure)
结局指标
主要结局
Number of patients developing pacemaker-induced cardiomyopathy
时间窗: 36 months
Echocardiographically detected deterioration in systolic LVEF of ≥10% to an absolute value of \< 50%
次要结局
- Left ventricular function(36 months)
- Left Ventricular Global Longitudinal Strain(36 months)
- Right ventricular function(36 months)
- NT-proBNP serum concentration (ng/L)(36 months)
- Quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score(36 months)
- 6-minute walk distance (meters)(36 months)
- All-cause mortality(36 months)
- Number of patients with a rehospitalization due to heart failure/cardiac decompensation(36 months)
- Number of patients with a rehospitalization due to pacemaker malfunction(36 months)
- Number of patients with a rehospitalization due to atrial arrhythmia(36 months)
- Number of patients experiencing a stroke or transient ischemic attack(36 months)
- Procedure-related complications(36 months)