Closed-Loop Stimulation Combined With Left Bundle Branch Area Pacing in Patients With Atrioventricular Conduction Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Heart Rate During Mental Stress
研究概览
简要总结
This prospective, single-center, crossover study evaluated the effects of closed-loop stimulation (CLS) compared with conventional accelerometer-based rate-adaptive pacing (VVIR) in patients with permanent atrial fibrillation undergoing left bundle branch area pacing (LBBAP). Chronotropic responses were evaluated during standardized mental and physical stress testing. Heart rate distribution during daily activity, functional capacity, quality of life, and device-related parameters were also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants were blinded to the programmed pacing mode. Investigators and outcome assessors were not blinded.
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
- •Permanent atrial fibrillation
- •Chronotropic incompetence
- •Permanent pacemaker with left bundle branch area pacing (LBBAP)
- •Ventricular pacing burden >50%
- •Ability to provide written informed consent
排除标准
- •Age <18 years
- •Inability or unwillingness to provide informed consent
研究组 & 干预措施
CLS followed by VVIR
Participants received closed-loop stimulation (CLS) during the first study period, followed by accelerometer-based VVIR pacing during the second study period.
干预措施: Closed-Loop Stimulation (Device)
CLS followed by VVIR
Participants received closed-loop stimulation (CLS) during the first study period, followed by accelerometer-based VVIR pacing during the second study period.
干预措施: Accelerometer-Based VVIR Pacing (Device)
VVIR followed by CLS
Participants received accelerometer-based VVIR pacing during the first study period, followed by closed-loop stimulation (CLS) during the second study period.
干预措施: Closed-Loop Stimulation (Device)
VVIR followed by CLS
Participants received accelerometer-based VVIR pacing during the first study period, followed by closed-loop stimulation (CLS) during the second study period.
干预措施: Accelerometer-Based VVIR Pacing (Device)
结局指标
主要结局
Change in Heart Rate During Mental Stress
时间窗: At the end of each 1-month pacing period
Change in heart rate (ΔHR) during the Paced Auditory Serial Addition Test (PASAT), calculated as the peak heart rate recorded during the test minus the baseline heart rate. The outcome was assessed under both closed-loop stimulation (CLS) and accelerometer-based VVIR pacing and expressed in beats per minute (bpm).
Change in Heart Rate During Isometric Handgrip
时间窗: At the end of each 1-month pacing period
Change in heart rate (ΔHR) during the 5-minute isometric handgrip test performed at 30% of maximal voluntary contraction, calculated as the peak heart rate recorded during the test minus the baseline heart rate. The outcome was assessed under both closed-loop stimulation (CLS) and accelerometer-based VVIR pacing and expressed in beats per minute (bpm).
Change in Heart Rate During Treadmill Exercise
时间窗: At the end of each 1-month pacing period
Change in heart rate (ΔHR) during the symptom-limited treadmill exercise test using the modified Bruce protocol, calculated as the peak heart rate achieved during exercise minus the baseline heart rate. The outcome was assessed under both closed-loop stimulation (CLS) and accelerometer-based VVIR pacing and expressed in beats per minute (bpm).
次要结局
- Exercise Duration During Treadmill Testing(At the end of each 1-month pacing period)
- Metabolic Equivalents Achieved During Treadmill Testing(At the end of each 1-month pacing period)
- Ventricular Pacing Percentage(At the end of each 1-month pacing period)
- Heart Rate Score During Daily Activity(At the end of each 1-month pacing period)
- Health-Related Quality of Life Assessed With the EQ-5D-5L Index(At the end of each 1-month pacing period)
- Self-Rated Health Assessed With the EQ VAS(At the end of each 1-month pacing period)
- Patient-Reported Pacing-Mode Preference(At the end of the study, after completion of both 1-month pacing periods)
研究者
Bartlomiej Wrobel
Assistant
University of Rzeszow