Clinical Study to Evaluate System Safety and Clinical Performance of the ConsultaTM CRT-D Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.
研究概览
简要总结
The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).
详细描述
The Consulta CRT-D is an investigational bi-ventricular device that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation and cardiac resynchronization therapy.
The study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 18 centers.
To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Consulta device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), unscheduled follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have an indication for a defibrillator.
- •Patients who are optimally treated with medication.
- •Patients who are New York Heart Association (NYHA) Class III or IV
排除标准
- •Patients with a life expectancy less than the duration of the study.
- •Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.
- •Patients with mechanical tricuspid heart valves.
研究组 & 干预措施
Implantation of Consulta CRT-D
Patients have an implant attempt with a Bi-ventricular Implantable Cardioverter Defibrillator
干预措施: Bi-ventricular Implantable Cardioverter Defibrillator (Device)
结局指标
主要结局
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.
时间窗: 1 month
Percentage of subjects without an unanticipated serious adverse device effects at 1-month post implant.Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis.
次要结局
- Adverse Events(1 month)
- System Performance Assessed by Holter Records(1 month follow-up)
- System Performance Assessed by Save to Disk Files(1 month follow-up)
- System Performance Assessed by Technical Observations(1 month follow-up)