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

Patent Foramen Ovale Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416426
• Other study ID #: RSHUNT
• Status: Completed
• Phase: N/A
• First received: January 11, 2018
• Last updated: January 30, 2018
• Start date: March 28, 2014
• Est. completion date: February 15, 2017

Study information

• Verified date: January 2018
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Closure; Foramen Ovale
• Foramen Ovale, Patent
• Patent Foramen Ovale

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual shunt rate at 9 months	Incidence of significant residual shunt (=moderate) was assessed.	9-month follow-up bubble contrast TEE
Secondary	Residual shunt rate at 3 months	Incidence of significant residual shunt (=moderate) was assessed.	3-month follow-up bubble contrast TEE