Effect of Rate-responsive Compared to VDD Pacing in Cardiac Resynchronization Therapy Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- distance walked during the 6MWT
研究概览
简要总结
This study aims to understand the best programming pacing mode for cardiac resynchronization therapy devices used to treat chronic heart failure.
详细描述
Cardiac resynchronization therapy (CRT) efficacy trials to date used atrial-synchronous biventricular pacing wherein there is no or minimal atrial pacing. However, bradycardia and chronotropic incompetence are common in this patient population.
Despite neutral results on hard clinical outcomes of the atrial support in CRT patients, it is not clear if a rate-responsive pacing may add incremental benefits on exercise capability.
The aim of this study is to assess the impact of RR pacing compare to VVD pacing in patients implanted with CRT devices in term of functional capacity, measured by the six-minute walking test (6MWT). This simple test has shown to be an independent predictors of mortality in this cohort of patients.
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
- Double (Participant, 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
- •Patients willing to participate in the study and signing the approved Patient Informed Consent (PIC) Form;
- •Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA).
- •Sinus rhythm at the time of CRT device implantation with heart rate at rest above 50 bpm.
排除标准
- •Permanent Atrial Fibrillation;
- •Inability to perform 6MWT;
- •Suboptimal HF drug therapy;
- •Heart rate at rest above 50 bpm.
结局指标
主要结局
distance walked during the 6MWT
时间窗: A consecutive 6-month treatment period with the same pacing mode.
distance walked during the 6-minute-walking-test (6MWT)
次要结局
未报告次要终点
研究者
Luca Donazzan
Cardiologist
Ospedale Centrale Bolzano