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

NCT03416426 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2018-01-31

No results posted yet for this study

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.

Conditions

  • Patent Foramen Ovale
  • Closure; Foramen Ovale

Interventions

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.

Sponsors & Collaborators

  • Gachon University Gil Medical Center

    lead OTHER

Principal Investigators

  • Woong Chol Kang, MD · Gachon University Gil Medical Center

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-28
Primary Completion
2017-02-15
Completion
2017-02-15
FDA Device
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03416426 on ClinicalTrials.gov