Study of a Comparison of the Pacemaker Automatic Features in Reduction of Ventricular Pacing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 385
- 试验地点
- 30
- 主要终点
- Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+
研究概览
简要总结
The COMPARE-Adapta study is a randomized, multi-center, prospective study conducted in China. The purpose of the study is to compare the ability of Search AV™+ and Managed Ventricular Pacing® (MVP®) to reduce ventricular pacing in dual chamber pacemaker-indicated patients. The COMPARE-Adapta study will also observe atrial fibrillation (AF) burden as demonstrated by Cardiac Compass® and the clinical profile Adapta® pacemaker patients.
详细描述
Recent studies suggest that chronic right ventricular pacing is associated with a variety of adverse effects in patients, particularly those with intact or intermittent atrioventricular (AV) conduction.
Medtronic Adapta® pacemakers include Managed Ventricular Pacing®, a pacing mode designed to promote intrinsic conduction, and also Search AV™+, a feature designed to reduce unnecessary ventricular pacing in patients with intact or intermittent AV conduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Signed and dated study informed consent
- •Class I or Class IIa pacemaker indication
- •Geographically stable and available for follow-up at the center for the length of the study
- •Age greater than 18
- •To be implanted with Adapta dual chamber pacemaker
排除标准
- •Unwillingness or inability to give written informed consent to participate in the Study
- •Patient with a previously implanted pacemaker/Implantable Cardioverter-Defibrillator (ICD)/Cardiac Resynchronization Therapy (CRT) device
- •Life expectancy of less than one year
- •Patient has a mechanical tricuspid heart valve
- •Medical conditions that preclude the testing requirement by the protocol or limit study participation
- •Patient has persistent 3rd degree atrioventricular (AV) block
- •Patient has persistent atrial fibrillation (AF)
- •Patient has neurogenic syncope
- •Patient has carotid sinus syndrome
- •Patient has hypertrophic obstructive cardiomyopathy
- •Inclusion in another clinical trial or study
研究组 & 干预措施
Managed Ventricular Pacing
Managed Ventricular Pacing group: programmed on
干预措施: Medtronic Adapta Dual Chamber Pacemaker (Device)
Search AV+
Search AV+: programmed on
干预措施: Medtronic Adapta Dual Chamber Pacemaker (Device)
结局指标
主要结局
Number of Participants With Decreased Percent of Ventricular Pacing Compared to MVP Using Search AV+
时间窗: 1 month post-implantation
次要结局
- Percent of Ventricular Pacing Stratified by Baseline AV Block Status (1st Degree - 1AVB)(1 month post-implantation)
- Percent of Ventricular Pacing Stratified by Baseline AV Block Status (3rd Degree Episodic - e3AVB)(1 month post-implantation)
- Change in Percent of Ventricular Pacing(from 1 month to 12 months post-implantation)
- Percent of Ventricular Pacing(12 months post-implantation)
- Percentage of Reduced Percent of Atrial Fibrillation (AF) Burden 1-month Post-Implant(1 month post-implantation)
- Number of Participants With Percent Ventricular Pacing Reduced to Lower Levels (<10%VP)(1 month post-implantation)
- Number of Participants With Decreased Percent Ventricular Pacing Stratified by Baseline Atrioventricular Block Status (No AVB - nAVB)(1 month post-implantation)
- Percent of Ventricular Pacing Stratified by Baseline AV Block Status (2nd Degree Type I & II - 2AVB)(1 month post-implantation)