Residual Shunt After Patent Foramen Ovale Device Closure in Patients With Cryptogenic Stroke

CompletedOBSERVATIONAL
Enrollment

47

Participants

Timeline

Start Date

March 28, 2014

Primary Completion Date

February 15, 2017

Study Completion Date

February 15, 2017

Conditions
Patent Foramen OvaleClosure; Foramen Ovale
Interventions
DEVICE

Amplatzer® PFO occluder or Gore® Septal Occluder

The closure procedure was performed under general anesthesia. After achieving femoral venous access, the PFO was crossed with a 5F multipurpose catheter, which was advanced into the left upper pulmonary vein and then exchanged over a 0.035 inch J-tipped stiff guidewire for an 8F or 9F guiding sheath. Procedural anticoagulation was initiated with 5000 units of intravenous heparin. After then additional heparin was administrated throughout procedure to maintain an activated clotting time of ≥250 seconds. Device size was selected based on TEE measurements of the distance between the PFO and the aortic root.

Trial Locations (1)

405-760

Gachon University Gil Medical Center, Incheon

All Listed Sponsors
lead

Gachon University Gil Medical Center

OTHER

NCT03416426 - Residual Shunt After Patent Foramen Ovale Device Closure in Patients With Cryptogenic Stroke | Biotech Hunter | Biotech Hunter