Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898361
Status:
UNKNOWN
Last Update Posted:
2021-05-24
First Post:
2020-09-13
Brief Title:
PFO Occlusion and Atrial Fibrillation
Sponsor:
University Hospital Saarland
Organization:
Universität des Saarlandes
Study Overview
Official Title:
Electrophysiological and Echocardiographic PREDICTors of Atrial Fibrillation Following Interventional Closure of Patent Foramen Ovale in Cryptogenic Stroke PREDICT-AF-PFO
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 66 patients in the PFO closure group compared with 04 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 46 patients in the intervention group vs 09 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None