BIO|CREATE Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ventilatory efficiency slope
研究概览
简要总结
The study assesses the effect of Closed Loop Stimulation (CLS) on the ventilatory efficiency slope and estimates the patient responder rate to CLS in patients with severe chronotropic incompetence treated with a cardiac resynchronization therapy (CRT) device.
详细描述
In patients with pharmacological refractory heart failure (HF), systolic dysfunction, and cardiac dyssynchrony, the cardiac resynchronization therapy (CRT) reduces the risk of death, and improves symptoms and quality of life.
A considerable portion (80%) of patients with a CRT indication has a chronotropic incompetence (CI). CI usually induces a stress intolerance which negatively affects the quality of life. In addition of being a marker of diminished exercise capacity, severe CI (sCI) may be an independent predictor of mortality.
The sensor-based rate adaption provided by the implanted CRT device delivers a possible therapeutic approach for the CI.
Usually, rate adaption is achieved by an accelerometer. The previous studies in terms of effectiveness of rate adaption in CRT patients with CI showed inconsistent results.
In addition to an accelerometer to deliver the rate adaption BIOTRONIK provides closed loop stimulation (CLS) as unique feature in a CRT device. CLS determines the appropriate heart rate based on intra-cardiac impedance measurements. These measurements reflect changes of the cardiac contraction dynamics in reaction to information coming from the autonomic nervous system. CLS takes the information on the contraction dynamics and translates it into an adequate heart rate adaptation, thus delivering physiologically appropriate therapy.
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, 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
- •CRT class I indication at time of implantation, according to current guidelines
- •Implantation of CRT-device including CLS > 6 months prior to enrollment
- •Stable heart failure status for at least 1 month
- •Optimal cardiovascular drug treatment according to current guidelines
- •NYHA class II or III
- •Patient is able to comply with the protocol
- •Patient provided written informed consent
- •Stable location of residence
排除标准
- •Planned cardiovascular intervention within the next 3 months
- •Admission for decompensated heart failure or acute coronary syndrome in the preceding 3 months
- •Ongoing symptoms of myocardial ischemia
- •Known persistent, long-standing persistent or permanent atrial fibrillation
- •COPD with GOLD ≥ 3
- •Planned absence of residence for more than one week during study period
- •Pregnant or breast-feeding women
- •Participation in another interventional clinical investigation
- •Age < 18 years
- •Placed in an institution due to official decree or judicial order
- •Dependent from the sponsor, the clinical site or the investigators
研究组 & 干预措施
Pacing mode with CLS
干预措施: Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS) (Device)
Intrinsic mode
干预措施: Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS) (Device)
结局指标
主要结局
Ventilatory efficiency slope
时间窗: 2 months
The slope of VE/VCO2 describes the ventilatory efficiency during effort, showing the amount of air that must be ventilated to eliminate 1 litre of CO2.
次要结局
未报告次要终点