PFO tRanscatether Occlusion Long-term Outcomes National Group (PROLONG) Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,360
- 主要终点
- Number of Participants with device- or procedure-related serious adverse events (Primary Safety Endpoint)
研究概览
简要总结
Patent foramen ovale (PFO) has been associated with cryptogenic stroke and transient ischemic attack (TIA) in young adults.
Evidence from randomized clinical trials (RCT) has shown that transcatheter PFO closure yields a 59% relative reduction in recurrent ischemic stroke compared to medical therapy in selected individuals.
However, the follow-up duration in these studies averaged around 4 years, while only two studies report a median follow-up beyond 10 years. Considering the relative youth of the patients undergoing this procedure (average age being under 50 years across all studies), we can reasonably anticipate a substantial post-PFO closure lifespan for these individuals. Consequently, it is imperative to gather more extensive long-term follow-up data among PFO closure recipients The PROLONG (PFO tRanscatether Occlusion Long-term Outcomes National Group) is an observational, retrospective, multicenter, national registry including men and women undergoing transcatheter PFO closure, with the aim of assessing the long-term (>10 years) efficacy and safety of this procedure.
详细描述
The PROLONG (PFO Transcatheter Occlusion Long-term Outcomes National Group) is an observational, retrospective, multicenter registry. It includes 1,360 subjects who underwent transcatheter patent foramen ovale (PFO) closure between 1999 and 2013 at 12 Italian high-volume Centers. Patients will have at least 10 years of follow-up post-procedure.
The primary objectives of the study are to evaluate the long-term clinical effectiveness of PFO closure by the incidence of left-sided embolic events and to evaluate safety by assessing serious device- or procedure-related adverse events. Secondary objectives include the incidence of new-onset atrial arrhythmias, the presence and severity of residual shunts, the incidence and severity of migraine symptoms, and bleeding events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Age ≥18 years;
- •Confirmed Patent Foramen Ovale (PFO);
- •Transcatheter Patent Foramen Ovale (PFO) closure with an Occluder device;
- •PFO closure procedure performed between 1999 and 2013.
排除标准
- •Age < 18 years;
- •Previous surgical or transcatheter PFO closure;
- •Patients without follow-up data available.
结局指标
主要结局
Number of Participants with device- or procedure-related serious adverse events (Primary Safety Endpoint)
时间窗: Duration of follow-up (minimum of 10 years)
Device- or procedure- related serious adverse events post device implant
Number of Participants with ischemic stroke, transient ischemic attack or systemic embolism (SE) post device implant (Primary Effectiveness Outcome)
时间窗: Duration of follow-up (minimum of 10 years)
The primary effectiveness outcome is the composite incidence of stroke, transient ischemic attack (TIA), and systemic embolism (SE) post-PFO closure.
次要结局
- Number of Participants with recurrent ischemic stroke(Time Frame: Duration of follow-up (minimum of 10 years))
- Number of Participants with with recurrent systemic embolism (SE)(Time Frame: Duration of follow-up (minimum of 10 years))
- Rate of Procedural Success(Time Frame: Duration of follow-up (minimum of 10 years))
- Rate of All-cause mortality(Time Frame: Duration of follow-up (minimum of 10 years))
- Rate of residual shunt(Time Frame: Duration of follow-up (minimum of 10 years))
- Incidence of Device-Related and procedure-related Complications(Time Frame: Duration of follow-up (minimum of 10 years))
- Number of Participants withrecurrent transient ischemic attack (TIA)(Time Frame: Duration of follow-up (minimum of 10 years))
- Incidence of bleeding events(Time Frame: Duration of follow-up (minimum of 10 years))
- Incidence of migraine symptoms(Time Frame: Duration of follow-up (minimum of 10 years))
- Incidence of Clinically Significant New Atrial Arrhythmia(Time Frame: Duration of follow-up (minimum of 10 years))
研究者
Cosmo Godino
Doctor
IRCCS Ospedale San Raffaele