PFO Occlusion and Atrial Fibrillation

Patent Foramen Ovale Clinical Trial

Official title:

Electrophysiological and Echocardiographic PREDICTors of Atrial Fibrillation Following Interventional Closure of Patent Foramen Ovale in Cryptogenic Stroke: PREDICT-AF-PFO

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898361
• Other study ID #: PREDICT-AF PFO
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: June 2022

Study information

• Verified date: May 2021
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• PFO closure
Interventional closure of a patent foramen oval preceded by an electrophysiological study

Locations

Country	Name	City	State
Germany	Universitätsklinikum des Saarlandes	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline heart rhythm, e.g. new-onset atrial fibrillation	Rate of detection of new-onset atrial fibrillation with Holter and loop recorder monitoring after electrophysiological study	1, 3, 6, 12 months
Secondary	Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study	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	1 month
Secondary	Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study	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	3 months
Secondary	Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study	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	6 months
Secondary	Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study	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	12 months
Secondary	Change in left atrial morphology (LA volume index) following PFO closure	Assessment of the change in left atrial morphology and function (LA volume index) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA volume index, physiologocal parameter	1 month
Secondary	Change in left atrial function (LA strain) following PFO closure	Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter	1 month
Secondary	Change in new-onset AF following PFO closure	Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG	1 month
Secondary	Change in left atrial morphology (LA volume index) following PFO closure	Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter	3 months
Secondary	Change in left atrial function (LA strain) following PFO closure	Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter	3 months
Secondary	Change in new-onset AF following PFO closure	Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG	3 months
Secondary	Change in left atrial morphology (LA volume index) following PFO closure	Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter	6 months
Secondary	Change in left atrial function (LA strain) following PFO closure	Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter	6 months
Secondary	Change in new-onset AF following PFO closure	Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG	6 months
Secondary	Change in left atrial morphology (LA volume index) following PFO closure	Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter	12 months
Secondary	Change in left atrial function (LA strain) following PFO closure	Assessment of the change in left atrial function (LA strain) during follow-up. Measurement: echocardiography, Unit of measure: Assessment of LA strain, physiologocal parameter	12 months
Secondary	Change in new-onset AF following PFO closure	Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG	12 months