Encore PFO Closure Device - The PerFOrm Trial

Status Recruiting

Clinical Trial Summary

The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.

Clinical Trial Description

This is a prospective, multicenter, randomized clinical study to determine the safety and effectiveness of the Encore PFO closure device, which is indicated for percutaneous, transcatheter closure of a patent foramen ovale (PFO) in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05537753
Study type	Interventional
Source	Encore Medical Inc.
Contact	Mike Corcoran
Phone	651-797-0913
Email	mcorcoran@encore-medical.com
Status	Recruiting
Phase	N/A
Start date	July 12, 2023
Completion date	October 2029

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See also
Status	Clinical Trial	Phase
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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