NCT03416426

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

Residual Shunt After Patent Foramen Ovale Device Closure in Patients With Cryptogenic Stroke: Serial Bubble Contrast Transesophageal Echocardiography Data

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: Gachon University Gil Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Patent Foramen Ovale
• Closure; Foramen Ovale

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-03-28
• Primary completion: 2017-02-15
• Completion: 2017-02-15
• First posted: 2018-01-31
• Last updated: 2018-01-31

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study