Status:
UNKNOWN
PFO Occlusion and Atrial Fibrillation
Lead Sponsor:
University Hospital, Saarland
Conditions:
Atrial Fibrillation New Onset
Embolic Stroke of Undetermined Source
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Interventional closure of patent foramen ovale (PFO) associates with reduced risk of stroke recurrence in patients with cryptogenic ischemic stroke as reported in the recent CLOSE and REDUCE trials. T...
Eligibility Criteria
Inclusion
- Previous embolic stroke with undetermined source with…
- palpitations with clinical indication for an electrophysiological study (control group)
- PFO and clinical indication for interventional PFO closure according to current guidelines (intervention group)
- Sinus rhythm at time of inclusion with no history of AF
- Planned EP study due to reported palpitations or documented burden of non-sustained atrial arrythymias (\>100 atrial ectopic beats /24 hours, atrial tachycardia)
- Written informed consent
Exclusion
- previously documented AF
- indication for therapeutic anticoagulation
- uncontrolled diabetes mellitus
- acute coronary syndrom or acute cardiac decompensation within the last 6 months before enrollment
- enrolled in another study
- BMI \> 40 kg/m²
- patients who are pregnant of breastfeeding life expectancy \< 6 months
- relevant peripheral artery disease
- substance abuse
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04898361
Start Date
January 15 2020
End Date
June 1 2022
Last Update
May 24 2021
Active Locations (1)
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1
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany, 66421