PFO Occlusion and Atrial Fibrillation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patent Foramen Ovale; Atrial Fibrillation New Onset; Embolic Stroke of Undetermined Source
• Intervention / Treatment: Procedure: PFO closure

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Recruiting
      • Universitätsklinikum des Saarlandes
      • Contact: Christian Ukena, MD; Phone Number: 004968411615912; Email: christian.ukena@uks.eu
      • Contact: Dominic Millenaar, MD; Phone Number: 004968411615912; Email: dominic.millenaar@uks.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: PFO closure; Interventional closure of a patent foramen oval preceded by an electrophysiological study
No Intervention: NO PFO; Patients with embolic stroke of undetermined source (ESUS) with NO patent foramen ovale (PFO) receiving a structured electrophysiological study due to palpitations. Extensive cardiac monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Change in new-onset AF following PFO closure	Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG	1 month
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
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
Change in new-onset AF following PFO closure	Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG	3 months
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
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
Change in new-onset AF following PFO closure	Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG	6 months
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
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
Change in new-onset AF following PFO closure	Assessment of new-onset AF during follow-up. Measurement: ECG, Holter ECG	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Saarland

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: September 13, 2020
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Arrhythmias, Cardiac; Stroke; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Ischemic Stroke; Atrial Fibrillation; Foramen Ovale, Patent; Embolic Stroke
• Other Study ID Numbers: PREDICT-AF PFO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No