Investigating new heart rhythm issues after closing a heart defect
New Onset of Atrial Fibrillation After Percutaneous Patent Foramen Ovale Closure - Na Homolce Hospital
Na Homolce Hospital · NCT06983613
This study is trying to see if closing a heart defect in patients who have had a stroke leads to new heart rhythm problems like atrial fibrillation or flutter.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Na Homolce Hospital (other) |
| Locations | 2 sites (Prague and 1 other locations) |
| Trial ID | NCT06983613 on ClinicalTrials.gov |
What this trial studies
This observational study examines the occurrence of new-onset atrial fibrillation and atrial flutter in patients who undergo percutaneous closure of patent foramen ovale (PFO) to prevent embolic strokes. It aims to assess the incidence of these arrhythmias, which are potential complications following the procedure, particularly within the early post-operative period. The study involves patients who have been indicated for PFO closure due to stroke and have provided informed consent. The findings could provide insights into the risks associated with PFO closure and help refine patient selection criteria.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who require PFO closure due to a history of stroke and have no prior history of atrial fibrillation or flutter.
Not a fit: Patients with a known history of atrial fibrillation, atrial flutter, or atrial tachycardia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the risks associated with PFO closure, potentially leading to improved patient outcomes and safer treatment protocols.
How similar studies have performed: Previous studies have indicated a low incidence of new-onset atrial fibrillation following PFO closure, suggesting that while this area has been explored, further investigation is warranted.
Eligibility criteria
Show full inclusion / exclusion criteria
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. Exclusion Criteria: * Patients with a known history of atrial fibrillation, atrial flutter, or atrial tachycardia.
Where this trial is running
Prague and 1 other locations
- Nemocnice na Homolce — Prague, Czechia (RECRUITING)
- Nemocnice na Homolce — Prague, Czechia (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiovascular Diseases