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

NCT ID: NCT03416426

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-28
• Study Completion Date: 2017-02-15

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.

Conditions

Patent Foramen Ovale; Closure; Foramen Ovale

Keywords

patent foramen ovale; PFO closure; residual shunt; bubble contrast transesophageal echocardiography

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Amplatzer® PFO occluder or Gore® Septal Occluder

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gachon University Gil Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Woong Chol Kang

Director of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Woong Chol Kang, MD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Locations

Gachon University Gil Medical Center

Incheon, , South Korea

Countries

South Korea

Other Identifiers

RSHUNT

Identifier Type: -

Identifier Source: org_study_id