Physiologic Pacing for Symptomatic First-Degree Heart Block
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Quality of Life per the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
研究概览
简要总结
The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms).
详细描述
The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms). Patient will undergo a comparative effectiveness study where patients with symptomatic first-degree heart block (pr interval ≥250ms) undergo left bundle pacing (3830 lead) and are randomized to DDD-50 vs Managed Ventricular pacing-50 (MVP-50; AAI-DDD 50) and undergo a crossover at 3 months. This study will compare two standard of care options utilizing Food and Drug Administration (FDA) approved devices. Patients are evaluated at baseline, 3 months, and 6 months in terms of patient symptoms, exercise capacity, arrhythmia burden, and patient activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Aged 18 or above
- •Ventricular Ejection Fraction (EF) > 50%
- •New York Heart Association (NYHA) class II-IV
- •PR interval ≥250ms
- •Narrow QRS duration (≤140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm
排除标准
- •Permanent atrial fibrillation (AF)
- •Patients who are unable to perform a 6 minute hall walk
- •Other serious medical condition with life expectancy of less than 1 year
- •Lack of capacity to consent
- •Pregnancy
- •Contraindication to use of the relevant study device or leads (as per current manuals from manufacturer)
结局指标
主要结局
Quality of Life per the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
时间窗: 6 months after pacemaker implantation.
Determine if pacemaker programming influences quality of life based on Minnesota Living with Heart Failure Questionnaire (MLHFQ)
次要结局
- Patient activity(6 months after pacemaker implantation.)
- Exercise capacity(6 months after pacemaker implantation.)
- Atrial fibrillation burden(6 months after pacemaker implantation.)
研究者
Daniel Kaiser
Principal Investigator
Ascension Health