Clinical trial NCT05558774: Long-term Outcomes After Percutaneous Closure of PFO
Official title: Long-term Echocardiographic and Clinical Outcomes After Percutaneous Closure of Patent Foramen Ovale
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Foramen Ovale, Patent
Echocardiography
Embolic Stroke
Atrial Fibrillation
Keywords: patent foramen ovale
transthoracic echocardiography
cerebrovascular insult
transient ischemic attack
atrial fibrillation
Lead sponsor: MC Medicor
Sponsor class: OTHER
Collaborators: name: University of Ljubljana, Faculty of Medicine
First posted: 2022-09-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included patients who met our inclusion criteria, regardless of age and gender.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: CVI
timeFrame: From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.
measure: TIA
timeFrame: From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.
measure: Death
timeFrame: From date of percutaneous closure until the date of death from any cause.
Secondary outcomes:
measure: AF
timeFrame: From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: MC Medicor
Study officials:
affiliation: MC Medicor
name: Marjeta Zorc, MD, PhD
role: STUDY_CHAIR
affiliation: MC Medicor
name: Marko Noc, MD, PhD
role: STUDY_DIRECTOR
References: