Master Study of the EVIA DR-T/DR/SR-T/SR Pacemaker

Biotronik SE & Co. KG1 个研究点分布在 1 个国家目标入组 175 人2009年6月

适应症Pacemaker Indication

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Pacemaker Indication
发起方: Biotronik SE & Co. KG
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)
状态: 已完成
最后更新: 14年前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2009年6月

结束日期

2010年3月

最后更新

14年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Biotronik SE & Co. KG

责任方

Sponsor

入排标准

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

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.