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CompletedNCT05558774Updated Oct 29, 2026Results posted

Long-term Outcomes After Percutaneous Closure of PFO

An observational study in Foramen Ovale, Patent, Echocardiography and Embolic Stroke, sponsored by MC Medicor. Completed at 1 site in Slovenia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by MC Medicor · Observational

Updated Oct 29, 2026Now CompletedResults posted+5 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
364
Ages
18 Years to 80 Years
Sex
All
01

Study 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 functional percutaneous closure.

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.

02

Conditions studied

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

Keywords

  • patent foramen ovale
  • transthoracic echocardiography
  • cerebrovascular insult
  • transient ischemic attack
  • atrial fibrillation
03

In context

Foramen Ovale, Patent

136 studies on the registry are indexed under Foramen Ovale, Patent; 47 are open to participants now.

This study's enrollment of 364 is above the median of 254 across 59 observational studies indexed under Foramen Ovale, Patent.

Browse Foramen Ovale, Patent studies →

Lead sponsor

This is the only study on the registry with MC Medicor as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
364 participants (actual)
Target follow-up
24 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. CVI

    Cerebrovascular insult

    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.

  2. TIA

    Transient ischemic attack

    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.

  3. Death

    From cardiac and non-cardiac reasons

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

  4. 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.

    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.

Secondary outcomes

  1. AF

    Atrial fibrillation

    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.

07

Results

Posted Oct 29, 2026
Limitations and caveats
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.

Participant flow

Participant flow — Overall Study
MilestoneIncluded Participants
Started364
Completed306
Not completed58
Withdrew: Physician decision9
Withdrew: Lost to follow-up18
Withdrew: Death8
Withdrew: Adverse event1
Withdrew: Lack of efficacy22

Outcome measures

PrimaryCVI

Cerebrovascular insult

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.
Reported as:
Number · participants
CVI
participantsRecurrent CVI
CVI1
PrimaryTIA

Transient ischemic attack

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.
Reported as:
Count of participants · Participants
TIA
ParticipantsRecurrent TIA
TIA2
PrimaryDeath

From cardiac and non-cardiac reasons

Time frame:
From the date of individual percutaneous closure until the date of death from any cause, up to 4397 days.
Reported as:
Count of participants · Participants
Death
ParticipantsDeath From Any Cause
Death8
SecondaryAF

Atrial fibrillation

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.
Reported as:
Count of participants · Participants
AF
ParticipantsParoxysmal or Permanent Atrial Fibrillation
AF6
PrimaryResidual 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.

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.
Reported as:
Count of participants · Participants
Residual Right-to-left Shunts
ParticipantsIncluded Participants
Residual Right-to-left Shunts15

Adverse events

Collected over From 6 months to more than 10 years. Mean and standard deviation (1957+1690), median with 25th-75th interquartile range 1457 (267-3447).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Detected Adverse Events8/355 (2.3%)3/355 (0.8%)2/355 (0.6%)
Most frequent serious events
Most frequent serious events
EventDetected Adverse Events
TIANervous system disorders2/355
CVINervous system disorders1/355
Most frequent other events
Most frequent other events
EventDetected Adverse Events
Temporary blindnessEye disorders2/355

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Included Participants
<=18 years0
Between 18 and 65 years345
>=65 years10
Age, Continuous
Age, Continuous(years)Included Participants
Mean44 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)Included Participants
Female173
Male182
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Included Participants
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White355
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Included Participants
Slovenia355
08

Study locations

1 site
  • MC Medicor
    Ljubljana, 1000, Slovenia
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: During the period of 24 months.

Access criteria: The Clinical Trials ID of the study.

10

Updates

1 registry update since Sep 25, 2026
Status
Status unknown→Completed
changed Oct 29, 2026
Results
Results posted
posted Oct 29, 2026
Primary completion
Jul 11, 2023→Oct 1, 2024 (actual)
Oct 29, 2026
Study completion
Jul 11, 2024→Oct 1, 2024 (actual)
Oct 29, 2026
Enrollment
300 (estimated)→364 (actual)
Oct 29, 2026
Primary outcomes
3 time frame changed, 1 added
What changed in the outcomes
  • AddedResidual Right-to-left ShuntsTime 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.
  • Time frameCVIFrom date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months. → 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.
  • Time frameTIAFrom date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months. → 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.
  • Time frameDeathFrom date of percutaneous closure until the date of death from any cause. → From the date of individual percutaneous closure until the date of death from any cause, up to 4397 days.
Oct 29, 2026
Documents
Oct 29, 2026
Secondary outcomes
1 time frame changed
What changed in the outcomes
  • Time frameAFFrom date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months. → 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.
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Status unknown→Completed
    Results posted
    Documents Protocol and statistical analysis plan ↗ posted · Informed consent form ↗ posted
    Primary completion Jul 11, 2023→Oct 1, 2024 (now actual)
    Study completion Jul 11, 2024→Oct 1, 2024 (now actual)
    Enrollment 300 (estimated)→364 (actual)
    Primary outcomes 3 time frame changed, 1 added
    What changed in the outcomes
    • AddedResidual Right-to-left ShuntsTime 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.
    • Time frameCVIFrom date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months. → 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.
    • Time frameTIAFrom date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months. → 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.
    • Time frameDeathFrom date of percutaneous closure until the date of death from any cause. → From the date of individual percutaneous closure until the date of death from any cause, up to 4397 days.
    Secondary outcomes 1 time frame changed
    What changed in the outcomes
    • Time frameAFFrom date of percutaneous closure until the date of the last contrast transthoracic echocardiogram, assessed up to 24 months. → 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.
    + 6 other changes: verification date, description, contact details, site details, data sharing statement and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT05558774
Lead sponsor
MC Medicor
Collaborators
University of Ljubljana, Faculty of Medicine
Responsible party
Sponsor
First posted
Sep 28, 2022
Start date
Jul 11, 2022
Primary completion
Oct 1, 2024
Completion
Oct 1, 2024
Results posted
Oct 29, 2026
Last update
Oct 29, 2026

Study contacts

Marjeta Zorc, MD, PhD
study chair · MC Medicor
Marko Noc, MD, PhD
study director · MC Medicor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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