Long-term Outcomes After Percutaneous Closure of PFO

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558774
• Other study ID #: Medicor-PFO
• Status: Recruiting
• Start date: July 11, 2022
• Est. completion date: July 11, 2024

Study information

• Verified date: September 2022
• Source: MC Medicor
• Contact: Maja Rojko, MD
• Phone: 041847572
• Email: rojko.maja[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 11, 2024
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Echocardiography
• Embolic Stroke
• Foramen Ovale, Patent

Locations

Country	Name	City	State
Slovenia	MC Medicor	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
MC Medicor	University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CVI	Cerebrovascular insult	From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.
Primary	TIA	Transient ischemic attack	From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.
Primary	Death	From cardiac and non-cardiac reasons	From date of percutaneous closure until the date of death from any cause.
Secondary	AF	Atrial fibrillation	From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.