Long-term Outcomes After Percutaneous Closure of PFO

Sponsor
MC Medicor (Other)
Overall Status
Recruiting
CT.gov ID
NCT05558774
Collaborator
University of Ljubljana, Faculty of Medicine (Other)
300
1
24
12.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Long-term Echocardiographic and Clinical Outcomes After Percutaneous Closure of Patent Foramen Ovale
    Actual Study Start Date :
    Jul 11, 2022
    Anticipated Primary Completion Date :
    Jul 11, 2023
    Anticipated Study Completion Date :
    Jul 11, 2024

    Outcome Measures

    Primary Outcome Measures

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

      Cerebrovascular insult

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

      Transient ischemic attack

    3. Death [From date of percutaneous closure until the date of death from any cause.]

      From cardiac and non-cardiac reasons

    Secondary Outcome Measures

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

      Atrial fibrillation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MC Medicor Ljubljana Slovenia 1000

    Sponsors and Collaborators

    • MC Medicor
    • University of Ljubljana, Faculty of Medicine

    Investigators

    • Study Chair: Marjeta Zorc, MD, PhD, MC Medicor
    • Study Director: Marko Noc, MD, PhD, MC Medicor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MC Medicor
    ClinicalTrials.gov Identifier:
    NCT05558774
    Other Study ID Numbers:
    • Medicor-PFO
    First Posted:
    Sep 28, 2022
    Last Update Posted:
    Sep 28, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by MC Medicor
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 28, 2022