NCT03416426|CompletedFDA Device
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Sponsor study identifier
observational
47
1 country
1
Study Start
March 28, 2014
Actual (reported)Primary Completion
February 15, 2017
Actual (reported)Study Completion
February 15, 2017
Actual (reported)Among consecutive 47 cryptogenic stroke patients who underwent PFO closure, a serial follow-up bubble contrast TEE at 3 and 9 months after the index procedure was completed in 38 patients (81%, 46±10 years, 19 men). To evaluate the efficacy of PFO closure, the incidence of any- and significant residual shunt (≥moderate) was assessed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2017
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 28, 2014
Actual (reported)February 15, 2017
Actual (reported)February 15, 2017
Actual (reported)January 11, 2018
Actual (reported)January 31, 2018
Actual (reported)Residual shunt rate at 9 months
Incidence of significant residual shunt (≥moderate) was assessed.
9-month follow-up bubble contrast TEE
Residual shunt rate at 3 months
3-month follow-up bubble contrast TEE
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
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.
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all consecutive 47 patients with ischemic stroke and PFO documented by BCTEE with no other identifiable cause of the ischemic event, such as, carotid or intracranial artery stenosis, atrial fibrillation, and thrombus, or atheromatous plaque at the aortic arch (i.e. CS), were analyzed. PFO closure was determined according to the heart-brain team's discretion (the team consisted of an interventional cardiologist, an echocardiographer cardiologist, a neurologist, and a radiologist) based on clinical data, echocardiographic findings, and patients' preference.
Gachon University Gil Medical Center
Incheon, 405-760, South Korea
Woong Chol Kang, MD
Gachon University Gil Medical Center
47 participants (actual enrollment reported by the registry).
First Submitted
January 11, 2018
First Posted
January 31, 2018
Study Start
March 28, 2014
Actual (reported)Does Patent Foramen Ovale Closure Improve Exercise Capacity & Prevent Blood Flow Through Intrapulmonary Shunt
Contact the study team to confirm eligibility.
Primary Completion
February 15, 2017
Actual (reported)Study Completion
February 15, 2017
Actual (reported)Last Updated
January 31, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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