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

Completed

• Conditions: Patent Foramen Ovale; Closure; Foramen Ovale
• Interventions: Device: Amplatzer® PFO occluder or Gore® Septal Occluder

• Registration Number: NCT03416426
• Lead Sponsor: Gachon University Gil Medical Center

Brief 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.

Study Timeline

• Study Start: 2014-03-28
• Primary Completion: 2017-02-15
• Study Completion: 2017-02-15
• Status Verified: 2018-01
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-30
• Last Update Submitted: 2018-01-30
• Study First Posted: 2018-01-31
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients undergone PFO closure	Amplatzer® PFO occluder or Gore® Septal Occluder	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

Primary Outcome Measures

Name	Time	Method
Residual shunt rate at 9 months	9-month follow-up bubble contrast TEE	Incidence of significant residual shunt (≥moderate) was assessed.

Secondary Outcome Measures

Name	Time	Method
Residual shunt rate at 3 months	3-month follow-up bubble contrast TEE	Incidence of significant residual shunt (≥moderate) was assessed.

Trial Locations

Locations (1)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of