Long-term Outcomes After Percutaneous Closure of PFO

September 25, 2022 updated by: MC Medicor

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Recruiting
        • MC Medicor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CVI
Time Frame: From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.
Cerebrovascular insult
From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.
TIA
Time Frame: From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.
Transient ischemic attack
From date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months.
Death
Time Frame: From date of percutaneous closure until the date of death from any cause.
From cardiac and non-cardiac reasons
From date of percutaneous closure until the date of death from any cause.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MC Medicor

Collaborators

University of Ljubljana, Faculty of Medicine

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 11, 2022

Primary Completion (ANTICIPATED)

July 11, 2023

Study Completion (ANTICIPATED)

July 11, 2024

Study Registration Dates

First Submitted

September 4, 2022

First Submitted That Met QC Criteria

September 25, 2022

First Posted (ACTUAL)

September 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 25, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medicor-PFO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

During the period of 24 months.

IPD Sharing Access Criteria

The Clinical Trials ID of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe