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

NCT06983613 | Recruiting

• 1 other identifier: Nemocnice Na Homolce IG250501
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (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.

  2025-2028

Secondary Outcomes (29)

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

  2025-2028

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

  2025-2028

• Risk factor at baseline.

  2025-2028

• Risk factor at baseline.

  2025-2028

• Risk factor at baseline.

  2025-2028

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Na Homolce Hospital: lead

Study Sites (2)

Nemocnice na Homolce

Prague, 15030, Czechia

RECRUITING

Nemocnice na Homolce

Prague, 15030, Czechia

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: May 21, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 21, 2025

Record last verified: 2025-04

Locations

CZ (2)