BackBeat Medical Cardiac Neuromodulation Therapy in Patients With Heart Failure: An Acute Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in Arterial Elastance
研究概览
简要总结
This investigation will evaluate the ability of the Moderato® System to safely and effectively deliver CNT, to reduce sympathetic activity in heart failure patients
详细描述
This will be a single center, non-randomized observational study. The Moderato® System is approved for marketing in Europe (has a CE mark) for the treatment of high blood pressure in patients requiring standard cardiac pacing. The therapy delivered by the Moderato® System is referred to as CNT (Cardiac Neuromodulation Therapy). Heart failure patients is a population for which the Moderato® device is currently not indicated.
Subjects requiring an implantable cardiac defibrillator (ICD) implantation or replacement and meeting study inclusion and exclusion criteria will be eligible to participate in the study. The study procedure will take place during the ICD implantation (or replacement).
The whole procedure will be performed according to standard of care for ICD implantations (or replacements) including periprocedural prophylactic antibiotics prophylactic. To reduce the time of wound exposure, the setup of system for invasive measurements will be done before the ICD implant (or replacement) procedure begins.
The groin area will be prepared and draped. After applying local anesthesia, a 7Fr sheath will be inserted into the femoral artery. A small dose of heparin (~5000 units) will be administered intravenously to prevent formation of blood clots. Under fluoroscopic guidance, a standard conductance catheter (CD Leycom CA-71103-PL, CE marked) will be advanced into the left ventricle.
The arterial line will be used to measure arterial pressure. This completes the measuring system setup.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Subject is ≥ 18 years of age
- •Subject has a primary indication and is scheduled for ICD implantation or replacement
- •Subject has heart failure NYHA Class II or III
排除标准
- •Subject is to receive a single chamber defibrillator
- •Subject has an ejection fraction of 25% or less
- •Subject's systolic blood pressure is less than 120 mm Hg on the day of implant
- •Subject has decompensated heart failure
- •Subject has significant (>2+) mitral regurgitation, aortic regurgitation or aortic stenosis.
- •Subject has permanent atrial fibrillation
- •Subject has atrial fibrillation on the day of the study.
- •Subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm
- •Subject has a history of prior neurological events (stroke or TIA) within the past year or a neurological event (stroke or TIA) at any prior time that has resulted in residual neurologic deficit.
- •Subject has a history of autonomic dysfunction
- •Women who are pregnant or breast-feeding
- •Subject cannot or is unwilling to provide informed consent.
结局指标
主要结局
Change in Arterial Elastance
时间窗: Immediate, derived form ongoing Pressure Volume changes in the Left ventricle
Arterial elastance is reduced when sympathetic activity is reduced, an indication of a relaxed peripheral resistance.
次要结局
未报告次要终点