Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04898361
Study type Interventional
Source Universität des Saarlandes
Contact
Status Recruiting
Phase N/A
Start date January 15, 2020
Completion date June 2022

See also
  Status Clinical Trial Phase
Completed NCT06192173 - Patent Foramen Ovale Closure in Migraine
Recruiting NCT04610463 - Evaluation of the Severity of Right to Left Shunt in PFO Patients After Systemic Embolism N/A
Completed NCT02882815 - Post Market Clinical Follow-up Study of IrisFITTM PFO (Patent Foramen Ovale) Occluder N/A
Completed NCT04604015 - RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt N/A
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Not yet recruiting NCT04549272 - Assessment of Early Vascular Damage With Advanced Neuroimaging in Patient With Patent Foramen Ovale
Completed NCT02621528 - Lifetech CeraFlex™ Post-Market Surveillance Study N/A
Terminated NCT01018355 - The Effect of Device Closure of Patent Foramen Ovale in Elderly Patients With Crytogenic Stoke/TCI N/A
Completed NCT00831259 - Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO) N/A
Not yet recruiting NCT05360771 - Study on the Safety and Effectiveness of the SnowyTM PFO Closure System N/A
Recruiting NCT05546320 - Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale Phase 4
Recruiting NCT05561660 - COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2) Phase 4
Completed NCT03904277 - Does Patent Foramen Ovale Size Matter in Men and Women
Recruiting NCT06120270 - CeraFlex PFO Closure System PMCF Study
Terminated NCT01773252 - Right to Left Cardiac Shunt Detection Phase 3
Completed NCT01216423 - Pulmonary Embolism and Stroke in Patient With Patent Foramen Ovale N/A
Completed NCT03377465 - Biomarkers, Hemodynamic and Echocardiographic Predictors of Ischemic Strokes and Their Influence on the Course and Prognosis N/A
Active, not recruiting NCT04738071 - International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Not yet recruiting NCT06413147 - Long-term Procedural and Device Related Complications of PFO Closure
Not yet recruiting NCT06344494 - Cardiac Interventional ICE Imaging Trial N/A