Long-term Outcomes After Percutaneous Closure of PFO

NCT05558774 | Unknown

• 1 other identifier: Medicor-PFO
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• CVI

  Cerebrovascular insult

  From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.

• TIA

  Transient ischemic attack

  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

  From date of percutaneous closure until the date of death from any cause.

Secondary Outcomes (1)

• AF

  From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We included patients who met our inclusion criteria, regardless of age and gender.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MC Medicor: lead
• University of Ljubljana, Faculty of Medicine: collaborator

Study Sites (1)

MC Medicor

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Foramen Ovale, Patent; Embolic Stroke; Atrial Fibrillation; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ischemic Stroke; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Ischemia

Study Officials

• Marjeta Zorc, MD, PhD

  MC Medicor

  STUDY CHAIR

• Marko Noc, MD, PhD

  MC Medicor

  STUDY DIRECTOR

Central Study Contacts

Maja Rojko, MD

CONTACT

041847572; rojko.maja@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 28, 2022
• Study Start: July 11, 2022
• Primary Completion: July 11, 2023
• Study Completion: July 11, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: During the period of 24 months.
• Access Criteria: The Clinical Trials ID of the study.

Locations

SL (1)