NCT06436053招募中不适用
Acute Response to Left Bundle Branch Area Pacing With SyncAV
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- QRS duration
研究概览
简要总结
This clinical investigation is a prospective, single-arm, post-market, non-randomized, single-center study designed to evaluate the effectiveness of the SyncAV CRT dynamic atrioventricular (AV) delay feature when used with left bundle branch area pacing (LBBAP).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient is 18 years of age and willing to comply with the study requirements
- •Patients with approved indication for dual-chamber pacing or cardiac resynchronization therapy and scheduled to be implanted with an Abbott pacing system
- •Patient has documented left bundle branch block (LBBB) or intraventricular conduction delay (IVCD)
- •Patient has an intrinsic QRS duration ≥ 130 ms
- •Patient has intact AV conduction with PR interval ≤ 250 ms
排除标准
- •Patient has a resting ventricular rate > 100 bpm
- •Patient has AV Block (2nd or 3rd degree)
- •Patient has documented persistent atrial tachycardia or atrial fibrillation
- •Patient has had a recent myocardial infarction, ablation, electrolyte imbalance, or any condition within the last 90 days that would contraindicate for pacing device programming changes in the opinion of the investigator
- •Patient is currently participating in another clinical investigation
- •Patient is pregnant or nursing
- •Patient has other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
- •Patient does not have legal authority
- •Patient is unable to read or write
结局指标
主要结局
QRS duration
时间窗: During the intervention/procedure/surgery
Acute change in surface ECG QRS duration resulting from left bundle branch area pacing with optimized SyncAV, relative to intrinsic atrioventricular conduction.
次要结局
- LV hemodynamics(During the intervention/procedure/surgery)
研究者
研究点 (2)
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