Safety and Performance Evaluation of the CircuLite Synergy Pocket Circulatory Assist Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 22
- 主要终点
- Safety - Adverse Events
研究概览
简要总结
The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device.
详细描述
The CircuLite Synergy Pocket Circulatory Assist Device is an implantable miniature, mixed-flow blood pump designed o provide partial left ventricular support in patients with advanced heart failure. Treatment for this patient population currently include lifestyle changes, medicines, transcatheter interventions and surgery, including implantation of mechanical ventricular assist devices (VADs); most of the currently available VADs require highly invasive, high-risk surgical procedures to implant due to large device size, and are therefore generally limited to use in patients with terminal heart failure. The Synergy pump is intended for treatment of patients with New York Heart Association (NYHA) Class III and IV heart failure; it is expected that the pump will provide these patients with 2-3 L/min of additional blood flow, giving adequate cardiac support to increase exercise tolerance and improve patients' quality of life. The pump's small size will allow it to be implanted in a less surgically invasive procedure than used with previous VADs, which should result in a reduction of perioperative morbidity. The device wil be implanted in a left atrial to subclavian artery bypass with the pump being located in the infraclavicular fossa like a pacemaker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maximum tolerable medical therapy including ACE inhibitors and Beta Blockers
- •NYHA Class III or IV despite maximal tolerable medical therapy
- •Ambulatory (inpatient or outpatient)
- •Patients on the heart transplant list (or, not currently listed but otherwise suitable for heart transplant)
- •Life expectancy of at least 6 months without full VAD support
排除标准
- •Age >75 years
- •Exercise tolerance limited by factors other than heart failure
- •Presence of intra-atrial thrombus
- •Clinically significant right heart failure
- •Serum creatinine >/= 2.5 mg/dl or any dialysis in previous 3 months
- •Evidence of intrinsic hepatic disease
- •Previous episode of resuscitated sudden death without subsequent treatment with AICD
- •Subclavian artery stenosis
- •Low platelet count, INR that cannot be corrected prior to implant or contraindication to anticoagulation
研究组 & 干预措施
Treatment with the pump
Treatment with the CircuLite Synergy Pocket Circulatory Assist Device
干预措施: CircuLite Synergy Pocket Circulatory Assist Device (Device)
结局指标
主要结局
Safety - Adverse Events
时间窗: 3 months
Evaluation of the incidences of device failure or malfunction, adverse events associated with device use, surgical complications with device implant, and demonstration that the device provides adequate circulatory support in advanced HF patients.
次要结局
- Change in hemodynamics(3 months)