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临床试验/NCT05558774
NCT05558774招募中不适用

Long-term Echocardiographic and Clinical Outcomes After Percutaneous Closure of Patent Foramen Ovale

MC Medicor1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
CVI

研究概览

简要总结

International medical centre Medicor from Slovenia has reported 306 successful percutaneous closures of patent foramen ovale (PFO) from October 2006 till June 2022. The investigators are going to follow-up the participants clinically and with contrast transthoracic echocardiography (TTE) to define the percentage of functional percutaneous closure. The latter is defined with the number (ten or less) of contrast-bubbles in the left atrium during Valsalva maneuver and contrast (agitated saline) application. The clinical follow-up will show the recurrence of embolic events (cerebrovascular insults, transient ischemic attacks) after percutaneous closure. In addition all of the participants are going to be screened for atrial fibrillation. The patients with moderate residual shunts (more than ten bubbles in the left atrium) will then according to the protocol have a transesophageal echocardiogram (TEE) to show the eventual mechanism of the shunt. If the TEE will not show any signs of a residual shunt, the patients will undergo a computed tomography angiogram (CTA) of the pulmonary circulation to exclude arterio-venous fistulas as a cause of the shunt seen on TTE. The investigators will also show the comparison in functional closure between classic and alternative device occluders.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who had a neurological event confirmed by a neurologist.
  • Patients who underwent percutaneous closure of PFO in MC Medicor (Slovenia) from 2006 to 2022.

排除标准

  • Patients who had additional congenital heart defects (as is atrial septal defects).
  • Professional divers, who had the percutaneous closure of PFO because of an episode of decompression sickness.

结局指标

主要结局

CVI

时间窗: From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.

Cerebrovascular insult

TIA

时间窗: From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.

Transient ischemic attack

Death

时间窗: From date of percutaneous closure until the date of death from any cause.

From cardiac and non-cardiac reasons

次要结局

  • AF(From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.)

研究者

发起方
MC Medicor
申办方类型
Other
责任方
Sponsor

研究点 (1)

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