An observational study in Patent Foramen Ovale and Closure; Foramen Ovale, sponsored by Gachon University Gil Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by Gachon University Gil Medical Center · Observational
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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.
The current investigation analyzed the date from the Gachon University Gil Medical Center PFO registry. Between March 2014 to February 2017, all consecutive 47 patients with ischemic stroke and PFO documented by bubble contrast 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. The Gore® Septal Occluder (WL Gore \& Associates, Inc., Newark, DE, USA) (n=19) and the Amplatzer® PFO occluder (St. Jude Medical, Inc. St.Paul, MN, USA) (n=19) and were used. The Occlutec® PFO occluder was used in one patient who were excluded from the analysis. The Institutional Review Board of Gachon University Gil Medical Center approved this study and all patients provided written informed consent prior to enrollment.
136 studies on the registry are indexed under Foramen Ovale, Patent; 47 are open to participants now.
This study's enrollment of 47 is below the median of 254 across 59 observational studies indexed under Foramen Ovale, Patent.
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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.
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patients with cryptogenic stroke and PFO documented by bubble contrast TEE
Exclusion Criteria:
patients with 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
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
Incidence of significant residual shunt (≥moderate) was assessed.
Time frame: 9-month follow-up bubble contrast TEE
Residual shunt rate at 3 months
Incidence of significant residual shunt (≥moderate) was assessed.
Time frame: 3-month follow-up bubble contrast TEE
Plan to share: No
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Ran from Mar 2014 to primary completion in Feb 2017, 34 months.
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Gachon University Gil Medical Center