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Cardiovascular DiseasesNCT06983613

New Onset of Arrhythmia After Patent Foramen Ovale (PFO) Closure

An observational study of Cardiovascular Diseases, run by Na Homolce Hospital at 2 sites in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Embolic stroke of undetermined source (ESUS) accounts for approximately 25% of all ischemic strokes, with patent foramen ovale (PFO) considered a major mechanism behind ESUS. When specific anatomic criteria are met, transcatheter PFO occlusion is regarded as the gold standard for secondary stroke prevention. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases
How many people
150 participants
Where
2 sitesCzechia
Study dates
15 Jan 2025to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study will include patients who have experienced ischemic stroke attributed to patent foramen ovale and for whom percutaneous closure has been recommended.

Who may be able to join

  • Indication for percutaneous closure of patent foramen ovale due to stroke, confirmed through an interdisciplinary meeting between cardiologists and neurologists, in accordance with current guidelines.
  • Age > 18 years.
  • Written informed consent.

Who cannot join

  • Patients with a known history of atrial fibrillation, atrial flutter, or atrial tachycardia.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Czechia2 sites, 2 recruiting

  • Nemocnice na Homolce

    Prague, 15030

    Martina Podolec, MD, 00420778710680, martina.podolec@homolka.cz

    Martin Mates, assoc. prof., 00420778710680, martin.mates@homolka.cz

    Recruiting

  • Nemocnice na Homolce

    Prague, 15030

    Martina Podolec, MD, +420778710680, martina.podolec@homolka.cz

    Martin Mates, assoc.prof, +420778710680, martin.mates@homolka.cz

    Recruiting

Other trials in Czechia

About this study

Official title: New Onset of Atrial Fibrillation After Percutaneous Patent Foramen Ovale Closure - Na Homolce Hospital

Embolic stroke of undetermined source (ESUS) accounts for approximately 25% of all ischemic strokes, with patent foramen ovale (PFO) considered a major mechanism behind ESUS. When specific anatomic criteria are met, transcatheter PFO occlusion is regarded as the gold standard for secondary stroke prevention.

However, previous studies have shown that percutaneous PFO closure may increase the risk of new-onset atrial fibrillation and atrial flutter (AF), arrhythmias that elevate the risk of embolic stroke. This raises concerns about performing PFO closure. Indeed, the most common clinically significant complication after catheter-based PFO closure is AF. Available data indicates that AF typically occurs in the early period following occluder implantation, with peak incidence around the 14th day post-closure, followed by a decline after the 45th day. Although AF is considered the most frequent adverse complication after percutaneous PFO occlusion, its incidence remains relatively low, ranging from 3% to 7.4%, depending on the method used for arrhythmia screening, though this remains unclear.

In this study, investigators will prospectively monitor patients who have experienced ESUS and are indicated for PFO closure. They will be screened for the occurrence of AF following percutaneous PFO closure using a 3-week ECG Holter monitor (from day 7 to day 28 post-closure) and again 1 week (one year post-closure) after the procedure. The study aims to determine the true incidence of new-onset AF following catheter-based PFO occlusion and to identify the risk factors associated with its development.

Medical subject headings
Cardiovascular Diseases

What is being measured

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

  1. New onset of atrial fibrillation after percutaneous patent foramen ovale closure - Na Homolce Hospital

    The primary endpoint - Number of participants with at least 1 episode of atrial arrythmia (atrial fibrillation, atrial flutter, atrial tachycardia), defined as any episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥ 30 seconds recorded on external cardiac monitor (ECG-Holter) during follow-up.

    Measured: 2025-2028

Secondary outcomes (29)

  1. Time to first episode of atrial arrythmia (atrial fibrillation, atrial flutter, atrial tachycardia) .

    Measured: 2025-2028

  2. Number of participants with new stroke or transient ischemic attack during follow up.

    Measured: 2025-2028

  3. Risk factor at baseline.

    Age - in years (at time of the procedure).

    Measured: 2025-2028

  4. Risk factor at baseline.

    Weight - in kilograms

    Measured: 2025-2028

  5. Risk factor at baseline.

    Height - in centimetres

    Measured: 2025-2028

  6. Risk factor at baseline.

    Body mass index (BMI) - in kg/m2

    Measured: 2025-2028

  7. Risk factor at baseline.

    Sex - male/female

    Measured: 2025-2028

  8. Risk factor at baseline.

    CHA₂DS₂-VASc Score for Atrial Fibrillation Stroke Risk

    Measured: 2025-2028

  9. Risk factor at baseline.

    Risk of Paradoxical Embolism (RoPE) Score - - in points (0-10)

    Measured: 2025-2028

  10. Risk factor at baseline.

    Number of participants with atrial hypertension

    Measured: 2025-2028

  11. Risk factor at baseline.

    Number of participants with Diabetes mellitus

    Measured: 2025-2028

  12. Risk factor at baseline.

    Number of participants with antidiabetic oral drugs

    Measured: 2025-2028

  13. Risk factor at baseline.

    Number of participants taking insulin

    Measured: 2025-2028

  14. Risk factor at baseline.

    Number of participants with hypercholesterolemia

    Measured: 2025-2028

  15. Risk factor at baseline.

    Number of participants actively smoking

    Measured: 2025-2028

  16. Risk factor at baseline.

    Number of participants formerly smoking

    Measured: 2025-2028

  17. Risk factor at baseline.

    Number of participants with peripheral embolism

    Measured: 2025-2028

  18. Risk factor at baseline.

    Number of participants with deep vein thrombosis

    Measured: 2025-2028

  19. Risk factor at baseline.

    Number of participants with coronary artery disease

    Measured: 2025-2028

  20. Risk factor at baseline.

    Left Atrial Volume Index in echocardiography - ml/m2

    Measured: 2025-2028

  21. Risk factor at baseline.

    Right Atrial Volume Index in echocardiography - ml/m2 or right atrial width/lenght in apical 4 chamber view in mm

    Measured: 2025-2028

  22. Risk factor at baseline.

    Left ventricle ejection fraction in %

    Measured: 2025-2028

  23. Risk factor at baseline.

    Left ventricle end-diastolic diameter - in mm

    Measured: 2025-2028

  24. Risk factor at baseline.

    Number of participants with presence of atrial septal aneurysm (assessed on preclosure echocardiography) defined as a septum mobility ≥10 mm from midline

    Measured: 2025-2028

  25. Risk factor at baseline.

    Presence of right to left shunt on pre-closure echocardiography - Small shunt referred to the appearance of 3 to 10 microbubbles, mild shunt referred to the appearance of 11 to 20 microbubbles, and severe shunt referred to the appearance of >20 microbubbles in the left atrium within 3 cardiac cycles after opacification of the right atrium

    Measured: 2025-2028

  26. Risk factor at baseline.

    Length of patent foramen ovale (PFO) canal - measured on transoesophageal echocardiography during the procedure in millimetres

    Measured: 2025-2028

  27. Risk factor at baseline.

    Height of patent foramen ovale (PFO) canal - measured on transoesophageal echocardiography during the procedure in millimetres, defined as the distance between the septum primum and septum secundum at maximum opening

    Measured: 2025-2028

  28. Risk factor at baseline.

    Invasive pressure measurement in right and left atrium - during the patent foramen ovale (PFO) closure procedure in mmHg

    Measured: 2025-2028

  29. Risk factor at baseline.

    Type and size of occluder

    Measured: 2025-2028

Timeline

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

  1. First posted21 May 2025
  2. Study start15 Jan 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06983613
Sponsor's protocol ID
Nemocnice Na Homolce IG250501
Status last verified
Apr 2025
First submitted
7 Mar 2025
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases, run by Na Homolce Hospital at 2 sites in Czechia.

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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia. 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New onset of atrial fibrillation after percutaneous patent foramen ovale closure - Na Homolce Hospital (time frame: 2025-2028). 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 NCT06983613.

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 21 May 2025.

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