Clinical trial NCT03416426: Residual Shunt After Patent Foramen Ovale Device Closure in Patients With Cryptogenic Stroke
Official title: Residual Shunt After Patent Foramen Ovale Device Closure in Patients With Cryptogenic Stroke: Serial Bubble Contrast Transesophageal Echocardiography Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Foramen Ovale
Closure; Foramen Ovale
Keywords: patent foramen ovale
PFO closure
residual shunt
bubble contrast transesophageal echocardiography
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Residual shunt rate at 9 months
timeFrame: 9-month follow-up bubble contrast TEE
Secondary outcomes:
measure: Residual shunt rate at 3 months
timeFrame: 3-month follow-up bubble contrast TEE
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center
name: Woong Chol Kang, MD
role: PRINCIPAL_INVESTIGATOR
References: