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.
Study Type
OBSERVATIONAL
Enrollment
300
MC Medicor
Ljubljana, Slovenia
RECRUITINGCVI
Cerebrovascular insult
Time frame: From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.
TIA
Transient ischemic attack
Time frame: From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.
Death
From cardiac and non-cardiac reasons
Time frame: From date of percutaneous closure until the date of death from any cause.
AF
Atrial fibrillation
Time frame: From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.
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