PFO Occlusion and Atrial Fibrillation

NCT04898361 | Unknown

• 1 other identifier: PREDICT-AF PFO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study

  1 month

• Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study

  3 months

• Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study

  6 months

• Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study

  12 months

• Change in left atrial morphology (LA volume index) following PFO closure

  1 month

Study Arms (2)

PFO closure

ACTIVE COMPARATOR

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

NO PFO

NO INTERVENTION

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.

Interventions

PFO closure PROCEDURE

Interventional closure of a patent foramen oval preceded by an electrophysiological study

PFO closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Saarland: lead

Study Sites (1)

Universitätsklinikum des Saarlandes

Homburg, Saarland, 66421, Germany

RECRUITING

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of cardiac electrophysiology department

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: May 24, 2021
• Study Start: January 15, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)