NCT00832260已完成不适用
Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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.
研究概览
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •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)
研究者
相似试验
已完成
不适用
AVAI: Atrial Ventricular Arrythmia IncidenceAtrial FibrillationVentricular TachycardiaNCT00832975Abbott Medical Devices157
已完成
不适用
Heart Rhythm Changes in Patients With Atrial Fibrillation After Cardiopulmonary Bypass: a Retrospective AnalysisAtrial FibrillationNCT06553391Chinese Academy of Medical Sciences, Fuwai Hospital106
已完成
不适用
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic StrokeIschemic StrokePremature Atrial ComplexesParoxysmal Atrial FibrillationNCT02610803Odense University Hospital863
Unknown
不适用
PREdicting Atrial Fibrillation or FlutterAtrial FibrillationAtrial FlutterNCT01851902Keesler Air Force Base Medical Center360
已完成
不适用
Autonomic Nervous System Dysregulation in People With Chronic Neck PainChronic Neck PainAutonomic Nervous SystemNCT06554704National Yang Ming Chiao Tung University56