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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05558774
Other study ID # Medicor-PFO
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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.
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