NCT00916344已完成不适用
Master Study of the EVIA DR-T/DR/SR-T/SR Pacemaker
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)
研究概览
简要总结
The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the indications for pacemaker therapy
- •Understand the nature of the procedure
- •Give informed consent
- •Able to complete all testing required by the clinical protocol
- •Available for follow-up visits on a regular basis at the investigational site
排除标准
- •Meet none of the pacemaker indications
- •Meet one or more of the contraindications
- •Patients with chronic atrial fibrillation (dual chamber pacemaker only)
- •Have a life expectancy of less than six months
- •Cardiac surgery in the next six months
- •Enrolled in another cardiac clinical investigation
- •Have other medical devices that may interact with the implanted pacemaker
研究组 & 干预措施
Pacemaker therapy
Experimental
干预措施: EVIA Pacemaker (Device)
结局指标
主要结局
Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)
时间窗: 1 month follow-up completed
atrial capture control: feature that automatically measures the atrial pacing threshold and subsequently adjusts the atrial pulse amplitude. atrial threshold test: measurable automatically or manually.
次要结局
- Complication Free Rate(1- and 3- month follow-up completed)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
ProMRI AFFIRM Study of the EVIA/ENTOVIS Pacemaker With Safio S Pacemaker LeadsCardiac DiseaseNCT01460992Biotronik SE & Co. KG121
已完成
不适用
EVITA: Evaluation of VIP Feature in Pacemaker PatientsArrhythmiaNCT00366158Abbott Medical Devices461
已完成
3 期
Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval StudySudden Cardiac DeathNCT00586378ELA Medical, Inc.85
已完成
不适用
Evia/Entovis HF-T Master StudyIndication for Cardiac Resynchronization Therapy (CRT)NCT01545739Biotronik SE & Co. KG122
招募中
不适用
Chronic Evaluation of Novel Pacemaker SystemVentricular Pacing With Rate ResponseBradycardiaNCT06056817Calyan Technologies10