Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2025-02-01
2025-02-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Persistent hypoxemia after Obstructive sleep apnea group
Participants will receive Patent Foramen Ovale (PFO) closure and followed until repeat sleep apnea testing up to 6 months.
PFO closure
The participants will receive a onetime closure of a small hole in heart. The procedure usually takes up to an hour. The procedure is done with local anesthesia and conscious sedation. A catheter is inserted into a vein in upper thigh and threaded to heart to deploy the closure device. Either Gore septal occluder or Amplatzer PFO occluder
Interventions
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PFO closure
The participants will receive a onetime closure of a small hole in heart. The procedure usually takes up to an hour. The procedure is done with local anesthesia and conscious sedation. A catheter is inserted into a vein in upper thigh and threaded to heart to deploy the closure device. Either Gore septal occluder or Amplatzer PFO occluder
Eligibility Criteria
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Inclusion Criteria
2. Individuals need to have a patent foramen ovale documented by echocardiography.
Exclusion Criteria
2. Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.
18 Years
80 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Eduardo De Marchena
Professor of Medicine and surgery
Principal Investigators
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Eduardo de Marchena, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Other Identifiers
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20181090
Identifier Type: -
Identifier Source: org_study_id
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