Foramen Ovale, PatentNCT05558774

Long-term Outcomes After Percutaneous Closure of PFO

An observational study of Foramen Ovale, Patent and Echocardiography, run by MC Medicor at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

International medical centre Medicor from Slovenia has reported 363 successful percutaneous closures of patent foramen ovale (PFO) from October 2006 till October 2023. The investigators are going to follow-up the participants clinically and with contrast transthoracic echocardiography (TTE) to define the percentage of… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Foramen Ovale, Patent, Echocardiography, Embolic Stroke
How many people: 364 participants
Where: 1 siteSlovenia
Study dates: 11 Jul 2022to 1 Oct 2024
How long will I take part?: 24 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

MC Medicor
Ljubljana, 1000

Other trials in Slovenia

About this study

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

Read the detailed description

In the mentioned time period from October 2006 to October 2023 we included 306 patients from the total number of 363 (84%), which met the inclusion criteria.

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 main purpose is 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 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
Medical subject headings: Foramen Ovale, Patent, Embolic Stroke, Atrial Fibrillation, Ischemic Attack, Transient

What is being measured

The primary outcome is the main question the study is designed to answer.

CVI
Cerebrovascular insult
Measured: From the date of individual percutaneous closure until the date of the last contrast transthoracic echocardiogram by protocol, in average 1.975 days from the procedure.
TIA
Transient ischemic attack
Measured: From the date of individual percutaneous closure until the date of the last contrast transthoracic echocardiogram by protocol, in average 1.975 days from the procedure.
Death
From cardiac and non-cardiac reasons
Measured: From the date of individual percutaneous closure until the date of death from any cause, up to 4397 days.
Residual Right-to-left Shunts
Participants who underwent percutaneous PFO closure and completed the scheduled contrast echocardiography follow-up assessments. Residual shunts were classified according to the number of microbubbles detected as complete closure (0 bubbles), functional closure (1-10 bubbles) and moderate residual shunts (more than 10 bubbles) in the left atrium. Only the moderate residual shunts are reported.
Measured: From the date of individual percutaneous closure until the date of the last contrast transthoracic echocardiogram by protocol, in average 1.975 days from the procedure.

Secondary outcomes (1)

AF
Atrial fibrillation
Measured: From the date of individual percutaneous closure until the date of the last contrast transthoracic echocardiogram by protocol, in average 1.975 days from the procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 20221 Oct 2024

First posted28 Sep 2022
Study start11 Jul 2022
Primary completion1 Oct 2024
Study completion1 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Foramen Ovale, PatentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 364 participants (actual)
Target duration: 24 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT05558774
Sponsor's protocol ID: Medicor-PFO
Status last verified: Oct 2026
First submitted: 4 Sep 2022
Last updated: 29 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of our included patients have signed an informed consent form. This and all of the information about their procedure and follow-up diagnostic is stored for each patient (electronic and physical). Other researchers can ask for the data, which will be presented anonymous.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Patent Foramen Ovale, Ischemic Stroke
Active, not recruiting
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Stroke, Patent Foramen Ovale
RecruitingPhase 3
Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy
Migraine Disease, Patent Foramen Ovale
Recruiting
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
Patent Foramen Ovale, Stroke

All Foramen Ovale, Patent trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Echocardiographic and Clinical Outcomes After Percutaneous Closure of Patent Foramen Ovale
ClinicalTrials.gov ID: NCT05558774
Acronym / sponsor ID: Medicor-PFO
Conditions: Foramen Ovale, Patent, Echocardiography, Embolic Stroke, Atrial Fibrillation
Keywords: patent foramen ovale, transthoracic echocardiography, cerebrovascular insult, transient ischemic attack, atrial fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 364 participants (actual)
Lead sponsor: MC MedicorUniversity, hospital or other
Collaborators: University of Ljubljana, Faculty of Medicine
Study start: 11 Jul 2022 (actual)
Primary completion: 1 Oct 2024 (actual)
Study completion: 1 Oct 2024 (actual)
First posted: 28 Sep 2022 (actual)
Results: Posted 29 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In the mentioned time period from October 2006 to October 2023 we included 306 patients from the total number of 363 (84%), which met the inclusion criteria.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Target follow-up: 24 Months

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: We included patients who met our inclusion criteria, regardless of age and gender.

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

CVI
Time frame: From the date of individual percutaneous closure until the date of the last contrast transthoracic echocardiogram by protocol, in average 1.975 days from the procedure.
Cerebrovascular insult
TIA
Time frame: From the date of individual percutaneous closure until the date of the last contrast transthoracic echocardiogram by protocol, in average 1.975 days from the procedure.
Transient ischemic attack
Death
Time frame: From the date of individual percutaneous closure until the date of death from any cause, up to 4397 days.
From cardiac and non-cardiac reasons
Residual Right-to-left Shunts
Time frame: From the date of individual percutaneous closure until the date of the last contrast transthoracic echocardiogram by protocol, in average 1.975 days from the procedure.
Participants who underwent percutaneous PFO closure and completed the scheduled contrast echocardiography follow-up assessments. Residual shunts were classified according to the number of microbubbles detected as complete closure (0 bubbles), functional closure (1-10 bubbles) and moderate residual shunts (more than 10 bubbles) in the left atrium. Only the moderate residual shunts are reported.

1 secondary outcome

AF
Time frame: From the date of individual percutaneous closure until the date of the last contrast transthoracic echocardiogram by protocol, in average 1.975 days from the procedure.

Results and safety

Results posted to the registry on 29 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Included Participants	364	306

Primary outcome: CVI

Time frame: From the date of individual percutaneous closure until the date of the last contrast transthoracic echocardiogram by protocol, in average 1.975 days from the procedure.. Number. Unit: participants

Measure	Recurrent CVI n = 355
Value	1

Primary outcome: TIA

Measure	Recurrent TIA n = 355
Value	2

Primary outcome: Death

Time frame: From the date of individual percutaneous closure until the date of death from any cause, up to 4397 days.. Count of participants. Unit: Participants

Measure	Death From Any Cause n = 355
Value	8

Primary outcome: Residual Right-to-left Shunts

Measure	Included Participants n = 306
Value	15

Population analysed: 306 of the 355 included patients completed the contrast echocardiography follow-up protocol.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From 6 months to more than 10 years. Mean and standard deviation (1957+1690), median with 25th-75th interquartile range 1457 (267-3447).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Detected Adverse Events	3 of 355 (0.8%)	2 of 355 (0.6%)	8 of 355

Limitations and caveats (from the sponsor): Because of a single centre and single operator observational design, our findings cannot be generalized. Use of closure device was not randomized but selected by the team and varied also upon the availability. Furthermore, our patients were not randomly assigned for repeat echocardiography beyond 6 months. Since several patients declined repeat echocardiography, the number of echocardiographic examinations at different time intervals after PFO closure is rather limited.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. All of our included patients have signed an informed consent form. This and all of the information about their procedure and follow-up diagnostic is stored for each patient (electronic and physical). Other researchers can ask for the data, which will be presented anonymous.

Related trials for Foramen Ovale, Patent

Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Patent Foramen Ovale, Ischemic Stroke
Active, not recruiting
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Stroke, Patent Foramen Ovale
RecruitingPhase 3
Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy
Migraine Disease, Patent Foramen Ovale
Recruiting
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
Patent Foramen Ovale, Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marjeta Zorc, MD, PhD study chair

MC Medicor

Marko Noc, MD, PhD study director

MC Medicor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Foramen Ovale, Patent and Echocardiography, run by MC Medicor at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CVI (time frame: From the date of individual percutaneous closure until the date of the last contrast transthoracic echocardiogram by protocol, in average 1.975 days from the procedure.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05558774.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.