Safety and Efficacy of Low-energy Electrical Cardioversion With or Without Bi-atrial Pacing in Patients With Post-operative Atrial Fibrillation in a Real World Setting - The DefiPace Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 10
- 主要终点
- Incidence of POAF
研究概览
简要总结
Prospective, non-interventional, multi-center, international registry in two phases in consecutive patients undergoing elective cardiac surgery.
The DefiPace registry is designed in two phases
- to document the standard of care in 50 patients with atrial fibrillation (AF)
- to assess the treatment and outcomes of patients with post-operative atrial fibrilllation using low-energy cardioversion and subsequent bi-atrial pacing in clinical practice in 100 patients
详细描述
Phase A Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery)
- Data regarding standard of care post-operative pacing and treatment of POAF, if applicable, will be collected from time of surgery until discharge
- No use of an external bi-atrial pacing device
- No use of Defipace
- In-hospital data will be collected for all patients
- Patients that developed POAF (n=50) will be followed-up with a phone call 30 days after surgery.
Phase B Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned TMA implantation
- In-hospital data will be collected for all patients
- Use of the DefiPace system for the treatment (low-energy cardioversion) and post-operative prevention (bi-atrial pacing) of POAF will be documented (n=100). These patients will be followed-up with a phone call 30 days after surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 is scheduled to undergo elective open chest cardiac surgery (bypass and / or valve surgery)
- •Patient is at least 18 years old
- •Patient with isolated bypass surgery is at least 70 years old
- •Patient with valve surgery is at least 60 years old
- •Patient provides written informed consent prior to the procedure
- •Phase B only: patient is scheduled for TMA implantation during the elective cardiac surgery and is potentially eligible for DefiPace use
排除标准
- •Clinical history of either permanent, persistend or paroxysmal atrial fibrillation
- •Permanent pacemaker/defibrillator, other intra-cardiac active implanted electronic devices
- •Minimally-invasive surgery
- •Recent stroke within the last 3 months
- •A history of or current endocarditis
- •Pregnacy at the time of surgery
研究组 & 干预措施
Phase A
Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery)
- Data regarding standard of care post-operative pacing and treatment of POAF, if applicable, will be collected from time of surgery until discharge
- No use of an external bi-atrial pacing device
- No use of Defipace
- In-hospital data will be collected for all patients
- Patients that developed POAF (n=50) will be followed-up with a phone call 30 days after surgery
干预措施: No intervention (Other)
Phase B
Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned TMA implantation
- In-hospital data will be collected for all patients
- Use of the DefiPace system for the treatment (low-energy cardioversion) and post-operative prevention (bi-atrial pacing) of POAF will be documented (n=100). These patients will be followed-up with a phone call 30 days after surgery
干预措施: No intervention (Other)
结局指标
主要结局
Incidence of POAF
时间窗: 30 days
Incidence of POAF
Termination of POAF
时间窗: 30 days
Termination of POAF
Energy requirements
时间窗: 30 days
Mean energy requirements (first/subsequent)
POAF recurrence
时间窗: 30 days
POAF recurrence/repeat cardioversions
Time in ICU
时间窗: 30 days
Time in ICU in hours
Procedural success
时间窗: 30 days
Procedural success
Time in POAF
时间窗: 30 days
Time in POAF (AF Burden)
Time to cardioversion
时间窗: 30 days
Median time to cardioversion
Time needed for electrode placement
时间窗: 30 days
Time needed for electrode placement
Number of shocks
时间窗: 30 days
Mean number of shocks per patient
次要结局
未报告次要终点