NCT07206602招募中不适用
A Pilot Study Assessing Outcomes Of Artificial Intelligence-Guided Left Bundle Branch Area Pacing For Cardiac Resynchronization In Heart Failure
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- CRT response rate
研究概览
简要总结
The purpose of this study is to compare the effectiveness of AI-guided LBBAP versus conventional LBBAP (not AI-guided) in improving CRT response rates and clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, 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
- •Age: 18 years or older.
- •Left Ventricular Ejection Fraction (LVEF): <50% within 6 months prior to enrollment.
- •QRS Duration: Resting QRS duration ≥ 130 ms on ECG OR anticipated right ventricular pacing > 40% OR device in place with right ventricular pacing > 40% within 6 months prior to enrollment.
- •Medical Therapy: Optimized on guideline-directed medical therapy for heart failure.
- •AI-ECG probability of low LVEF: >0.5
排除标准
- •Age less than 18 years old
- •Inability to follow-up
- •Pregnancy
研究组 & 干预措施
AI-guided
Experimental
干预措施: AI-assisted Left Bundle Branch Area Pacing (Device)
Control
Active Comparator
干预措施: Left Bundle Branch Area Pacing (Procedure)
结局指标
主要结局
CRT response rate
时间窗: Baseline, 6 months
CRT response is defined as an absolute increase of \>5% in left ventricular ejection fraction (LVEF) after 6 months of CRT
次要结局
- NYHA (New York Heart Association) Class(Baseline, 6 months)
- Number of Hospitalizations(6 months)
- Number of Deaths(6 months)
- Left Ventricular Linear Dimensions(Baseline, 3 months)
- Left Ventricular Linear Volume(Baseline, 3 months)
- Procedural success: LBBAP-conventional arm(Baseline)
- Procedural success: AI-LBBAP arm(Baseline)
- Fluoroscopy time(Baseline, Approximately 30 minutes)
- Total procedure time(Baseline, Approximately 1-2 hours)
- Lead pacing thresholds(Baseline)
- Impedance(Baseline)
- Sensing Parameters(Baseline)
研究者
Fatima M. Ezzeddine
Principal Investigator
Mayo Clinic
研究点 (1)
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