Arrhythmia Burden in Patients With Impulse Dynamics Optimizer Cardiac Contractility Modulation (CCM) Device Implantation: Retrospective and Prospective Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Atrial Fibrillation (AF) Burden
研究概览
简要总结
The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF). Many candidates of this device have a previously implanted cardiovascular implantable electronic device (CIED)- internal cardioverter defibrillator (ICD) or permanent pacemaker (PM). Patients with heart failure are at high risk for both atrial and ventricular cardiac arrhythmias.
The aim of this study is to evaluate patients for Atrial fibrillation (AF) burden episode data obtained from interrogation of their CIED 8 months or greater after Optimizer implant and compare arrhythmia burden 6 months before Optimizer Cardiac Contractility Modulation (CCM) device insertion to 8 months or greater after Optimizer insertion (after 2 month blanking period).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •1%≤AF burden≤99% in the 6 month period prior to Optimizer implant as documented the patient's CIED
- •18 years of age or older on day of signing consent
- •Functional pacemaker or ICD and using remote follow-up for their CEID
- •Not scheduled for planned catheter ablation or cardioversion
- •Ability to sign consent in English or Spanish
排除标准
- •Permanent atrial fibrillation
- •Pregnancy (in prospective arm only)
- •Expected survival <1 year
结局指标
主要结局
Change in Atrial Fibrillation (AF) Burden
时间窗: 8 months post optimizer implantation
Compare the AF burden noted 6 months pre Optimizer implant to 6 post Optimizer months (post Optimizer months 3-8), after 2 month blanking period
次要结局
未报告次要终点