Long-term Outcomes After Percutaneous Closure of PFO

Recruiting

• Conditions: Echocardiography; Embolic Stroke; Atrial Fibrillation; Foramen Ovale, Patent

• Registration Number: NCT05558774
• Lead Sponsor: MC Medicor

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-11
• Status Verified: 2022-09
• Study First Submitted: 2022-09-04
• Study First Submitted QC: 2022-09-25
• Last Update Submitted: 2022-09-25
• Study First Posted: 2022-09-28
• Last Update Posted: 2022-09-28
• Primary Completion: 2023-07-11
• Study Completion: 2024-07-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CVI	From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.	Cerebrovascular insult
TIA	From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.	Transient ischemic attack
Death	From date of percutaneous closure until the date of death from any cause.	From cardiac and non-cardiac reasons

Secondary Outcome Measures

Name	Time	Method
AF	From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.	Atrial fibrillation

Trial Locations

Locations (1)

MC Medicor; 🇸🇮 Ljubljana, Slovenia