Long-term Clinical Outcomes and Prognostic Factors After Percutaneous Patent Foramen Ovale Closure: A Retrospective Cohort Study With Prospective Registry Extension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of participants with recurrent ischemic stroke or transient ischemic attack
研究概览
简要总结
Patent foramen ovale (PFO) is a congenital interatrial communication present in about one quarter of the general population and is recognized as a major cause of cryptogenic stroke. Percutaneous PFO closure reduces recurrent stroke, but a residual right-to-left shunt persists in 20 to 40 percent of patients after device implantation. Long-term data on device performance, the evolution of residual shunt over time, new-onset atrial fibrillation and other prognostic factors remain limited.
This single-center registry evaluates the long-term efficacy and safety of percutaneous PFO closure and identifies the clinical, anatomical, procedural and pharmacological factors associated with clinical and echocardiographic outcomes. The registry combines a retrospective cohort of patients treated at Severance Hospital between 2010 and March 2026 with a prospective registry extension that enrolls patients undergoing PFO closure after institutional review board approval, with follow-up for up to 119 months.
Clinical outcomes include recurrent ischemic stroke or transient ischemic attack, all-cause death, device-related complications and new-onset atrial fibrillation. Echocardiographic outcomes are assessed by serial agitated saline transthoracic echocardiography, which allows the presence, grade and longitudinal trajectory of residual shunt to be characterized.
详细描述
Design: ambispective observational registry conducted at Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Part A (retrospective cohort): consecutive patients aged 19 years or older who underwent percutaneous PFO closure between 2010 and March 2026 and had at least one post-procedural agitated saline transthoracic echocardiography. Data are collected by direct review of electronic medical records, with the data cut-off set at the date of institutional review board approval. The requirement for informed consent is waived for this part.
The retrospective component comprises approximately 140 patients who underwent closure between 2010 and March 2026. A subgroup of these patients underwent two or more serial agitated saline transthoracic echocardiography examinations and is analyzed for the longitudinal trajectory of residual shunt.
Part B (prospective registry extension): patients aged 19 years or older who undergo percutaneous PFO closure after institutional review board approval and provide written informed consent. Follow-up visits are scheduled at 6, 12, 24, 48, 72, 96 and 119 months. Agitated saline transthoracic echocardiography is performed 6 months after closure and repeated at subsequent follow-up visits as clinically indicated.
Data collected: demographics and body mass index, smoking status, comorbidities (hypertension, diabetes mellitus, dyslipidemia, atrial fibrillation, coronary artery disease, deep vein thrombosis, pulmonary embolism, hypercoagulable state), index event characteristics (stroke or transient ischemic attack type, TOAST classification, brain imaging, Risk of Paradoxical Embolism score), echocardiographic and anatomical variables (atrial septal aneurysm and excursion distance, septal hypermobility, PFO tunnel length, PFO opening size, Eustachian valve, Chiari network, left ventricular ejection fraction), procedural variables (device type and size, guidance modality, balloon sizing, procedure time, fluoroscopy time, procedural complications), antithrombotic therapy, serial agitated saline transthoracic echocardiography results, clinical events and modified Rankin Scale.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 years or older
- •Percutaneous patent foramen ovale closure
- •Retrospective cohort: closure performed between 2010 and March 2026, with at least one post-procedural agitated saline transthoracic echocardiography
- •Prospective cohort: closure performed after institutional review board approval, with written informed consent
排除标准
- •Atrial septal defect closure (defect other than patent foramen ovale)
- •Device embolization or device removal
- •Echocardiographic image quality inadequate for assessment of shunt
- •Prospective cohort: refusal of informed consent
结局指标
主要结局
Number of participants with recurrent ischemic stroke or transient ischemic attack
时间窗: From patent foramen ovale closure to the last clinical follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort
First recurrent ischemic stroke or transient ischemic attack after closure, identified from medical records and classified by event type and TOAST criteria. Reported as the number of participants with an event and as the event rate per 100 patient-years.
Number of participants with residual right-to-left shunt on agitated saline transthoracic echocardiography, by shunt grade
时间窗: From patent foramen ovale closure to the last follow-up echocardiography: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort
Residual right-to-left shunt is defined as the appearance of microbubbles in the left heart within three cardiac cycles after right atrial opacification. Shunt grade is assigned from the maximum microbubble count: small (1 to 10), moderate (11 to 30) or large (more than 30). Reported as the number of participants in each grade.
次要结局
- Number of participants who die from any cause(From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort)
- Number of participants with device-related complications(From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort)
- Number of participants with new-onset atrial fibrillation(From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort)
- Number of participants with the composite of recurrent ischemic stroke or transient ischemic attack, all-cause death, or device-related complications(From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort)
- Longitudinal pattern of residual shunt on serial agitated saline transthoracic echocardiography(From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort)
- Time to spontaneous resolution of residual shunt(From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort)
- Predictors of residual right-to-left shunt on agitated saline transthoracic echocardiography(From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort)
- Functional status measured with the modified Rankin Scale(From patent foramen ovale closure to the last follow-up: up to 16 years in the retrospective cohort and up to 119 months in the prospective cohort)