Long-term Outcomes After Percutaneous Closure of PFO

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05558774

Enrollment

300

Registered

2022-09-28

Start date

2022-07-11

Completion date

2024-07-11

Last updated

2022-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

patent foramen ovale, transthoracic echocardiography, cerebrovascular insult, transient ischemic attack, atrial fibrillation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Slovenia

Contacts

Primary ContactMaja Rojko, MD

rojko.maja@gmail.com041847572

Outcome results