PFO Occlusion and Atrial Fibrillation

University Hospital, Saarland

Status: Unknown

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

Treatments: Procedure: PFO closure

Study type: Interventional

Funder types: Other

Identifiers

NCT04898361

PREDICT-AF PFO

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

PFO closure

Active Comparator group

Description:

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.

Treatment:

Procedure: PFO closure

NO PFO

No Intervention group

Description:

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.