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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PFO Occlusion and Atrial Fibrillation

NCT04898361

Atrial Fibrillation New Onset Embolic Stroke of Undetermined Source Patent Foramen Ovale

UNKNOWN NA

Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia

NCT05213104

Patent Foramen Ovale Atrial Arrhythmia Cryptogenic Stroke

ACTIVE_NOT_RECRUITING PHASE3

Ablation of Focal Activation in Atrial Fibrillation

NCT06402617

Atrial Fibrillation Atrial Fibrillation, Persistent Arrhythmia +2 more

RECRUITING NA

Atrial Fibrillation After PFO Closure

NCT04290052

Stroke

COMPLETED

Occult Paroxysmal Atrial Fibrillation in Patients With Non-cardioembolic Ischemic Stroke of Determined Mechanism

NCT01410396

Atrial Fibrillation Stroke

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.