Clinical trial NCT04898361: PFO Occlusion and Atrial Fibrillation
Official title: Electrophysiological and Echocardiographic PREDICTors of Atrial Fibrillation Following Interventional Closure of Patent Foramen Ovale in Cryptogenic Stroke: PREDICT-AF-PFO
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation New Onset
Embolic Stroke of Undetermined Source
Patent Foramen Ovale
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in baseline heart rhythm, e.g. new-onset atrial fibrillation
timeFrame: 1, 3, 6, 12 months
Secondary outcomes:
measure: Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study
timeFrame: 1 month
measure: Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study
timeFrame: 3 months
measure: Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study
timeFrame: 6 months
measure: Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study
timeFrame: 12 months
measure: Change in left atrial morphology (LA volume index) following PFO closure
timeFrame: 1 month
measure: Change in left atrial function (LA strain) following PFO closure
timeFrame: 1 month
measure: Change in new-onset AF following PFO closure
timeFrame: 1 month
measure: Change in left atrial morphology (LA volume index) following PFO closure
timeFrame: 3 months
measure: Change in left atrial function (LA strain) following PFO closure
timeFrame: 3 months
measure: Change in new-onset AF following PFO closure
timeFrame: 3 months
measure: Change in left atrial morphology (LA volume index) following PFO closure
timeFrame: 6 months
measure: Change in left atrial function (LA strain) following PFO closure
timeFrame: 6 months
measure: Change in new-onset AF following PFO closure
timeFrame: 6 months
measure: Change in left atrial morphology (LA volume index) following PFO closure
timeFrame: 12 months
measure: Change in left atrial function (LA strain) following PFO closure
timeFrame: 12 months
measure: Change in new-onset AF following PFO closure
timeFrame: 12 months
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
Study officials:
References: