PFO Occlusion and Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

PFO closure

Intervention Type PROCEDURE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PFO closure

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No