Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.

Abbott Medical Devices0 个研究点目标入组 70 人2009年1月

适应症Sinus Bradycardia Sinus Node Disease Atrio-ventricular Block

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Sinus Bradycardia
发起方: Abbott Medical Devices
入组人数: 70
主要终点: Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.
状态: 已完成
最后更新: 7年前

概览研究者入排标准结局指标相似试验

概览

简要总结

The purpose of this observational study is to collect data regarding the population of patients with a pacemaker implanted.

详细描述

The purpose of this observational study is to collect data regarding the population of patients whit a Zephyr™ pacemaker implanted, models 5826 and 5820, and active or passive fixation leads , when the Algorithms Acap Confirm, which automatically regulates the Atrial Pulse Width, is enabled.

注册库

clinicaltrials.gov

开始日期

2009年1月

结束日期

2013年9月

最后更新

7年前

研究类型

Observational

性别

All

研究者

发起方

Abbott Medical Devices

责任方

Sponsor

入排标准

入选标准

•Patient has an indication for implantation of a dual-chamber pacemaker;
•Patient is older than 18 years of age
•Patient has signed the study specific Informed consent document.
•Primo implant.

排除标准

•Patient is pregnant or nursing
•Patient is less than 18 years of age
•Patient is in New York Heart Association (NYHA) class III and IV.
•Patient has a pacemaker replacement;
•Patient is unable to attend the follow-up visits;

结局指标

主要结局

Percentage of Patients in Whom ACap™ Confirm Algorithm is Programmed Safely to ON During the First 12 Months.

时间窗: 12 months

次要结局

Percentage of Patients in Whom ACap™ Confirm Algorithm is Recommended at a Pulse Width of 0.4 Milliseconds (ms) During All Follow-ups (Implant, Staples Removal, 3, 6, 9 and 12 Months).(12 months)