Residual Shunt After Patent Foramen Ovale Device Closure in Patients With Cryptogenic Stroke
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|ClinicalTrials.gov Identifier: NCT03416426|
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment|
|Patent Foramen Ovale Closure; Foramen Ovale||Device: Amplatzer® PFO occluder or Gore® Septal Occluder|
|Study Type :||Observational|
|Actual Enrollment :||47 participants|
|Official Title:||Residual Shunt After Patent Foramen Ovale Device Closure in Patients With Cryptogenic Stroke: Serial Bubble Contrast Transesophageal Echocardiography Data|
|Actual Study Start Date :||March 28, 2014|
|Actual Primary Completion Date :||February 15, 2017|
|Actual Study Completion Date :||February 15, 2017|
patients undergone PFO closure
patients with ischemic stroke and PFO documented by bubble contrast TEE with no other identifiable cause of the ischemic event who undergone PFO closure using Amplatzer® PFO occluder or Gore® Septal Occluder
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.
- Residual shunt rate at 9 months [ Time Frame: 9-month follow-up bubble contrast TEE ]Incidence of significant residual shunt (≥moderate) was assessed.
- Residual shunt rate at 3 months [ Time Frame: 3-month follow-up bubble contrast TEE ]Incidence of significant residual shunt (≥moderate) was assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416426
|Korea, Republic of|
|Gachon University Gil Medical Center|
|Incheon, Korea, Republic of, 405-760|
|Principal Investigator:||Woong Chol Kang, MD||Gachon University Gil Medical Center|