PFO Occlusion and Atrial Fibrillation

Not Applicable

• Conditions: Embolic Stroke of Undetermined Source; Patent Foramen Ovale; Atrial Fibrillation New Onset
• Interventions: Procedure: PFO closure

• Registration Number: NCT04898361
• Lead Sponsor: University Hospital, Saarland

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. The long-term follow-up results of the RESPECT and DEFENSE-PFO trial confirmed these findings. PFO closure is therefore recommended in patient with cryptogenic ischemic stroke and PFO according to the current German interdisciplinary guidelines. It is likely that the number of PFO closure procedures will increase significantly in the near future. However, new onset atrial fibrillation (AF) appears to increase in patients following this procedure. In the REDUCE study, new onset atrial fibrillation was detected in 6.6% patients in the PFO closure group compared with 0.4% in the control group (medical treatment); 59% of these patients were diagnosed within the first two weeks following the procedure and 83% within 45 days, respectively. These results were consistent with the CLOSE study: AF was detected in 4.6% patients in the intervention group vs. 0.9% in the control group. Up until today, markers to identify and quantify the individual risk of AF onset are lacking. Furthermore, under-reporting and under-detection of AF occurrence after PFO closure is likely. This study is designed to to assess the prevalence and and identification of electrophysiological and echocardiographic parameters of new-onset AF.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-15
• Study First Submitted: 2020-09-13
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-19
• Last Update Submitted: 2021-05-19
• Study First Posted: 2021-05-24
• Last Update Posted: 2021-05-24
• Primary Completion: 2021-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PFO closure	PFO closure	Patients with embolic stroke of undetermined source (ESUS) with patent foramen ovale (PFO) eligible for interventional PFO occlusion receiving a structured electrophysiological study due to palpitations before the PFO closure. Extensive cardiac monitoring.

Primary Outcome Measures

Name	Time	Method
Change in baseline heart rhythm, e.g. new-onset atrial fibrillation	1, 3, 6, 12 months	Rate of detection of new-onset atrial fibrillation with Holter and loop recorder monitoring after electrophysiological study

Secondary Outcome Measures

Name	Time	Method
Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study	12 months	Atrial refractory periods are measured and atrial arrhythmias are induced during the electrophysiological study. Measurement: electrophysiological study, Unit of measure: Rate of patients with induced AF during stimulation
Change in left atrial morphology (LA volume index) following PFO closure	12 months	Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter
Change in left atrial function (LA strain) following PFO closure	12 months	Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter
Change in new-onset AF following PFO closure	12 months	Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG

Trial Locations

Locations (1)

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg, Saarland, Germany