Percutaneous closure of patent foramen ovale using radiofrequency energy

Not Applicable

• Conditions: Patent foramen ovale; Stroke; Migraine; Decompression sickness; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12613000225718
• Lead Sponsor: Royal Prince Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Age >/= 18 years, patent foramen ovale, morbidity suspected of being related to patent foramen ovale

Exclusion Criteria

Pregnancy, age <18 years, patent foramen ovale tunnel diameter >4 mm

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Closure of patent foramen ovale. This will be assessed by transesophageal echocardiogram performed 6 weeks post procedure.[6 weeks]

Secondary Outcome Measures

Name	Time	Method
Safety of procedure. Complications monitored for include significant bleeding post procedure, stroke, heart attack, heart perforation and death.[0-6 weeks]