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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UNKNOWN
NA
250 participants
INTERVENTIONAL
2017-11-20
2022-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PFO Closure Rate
Evaluate closure rate of clinically relevant septal defects including PFO, ASD (less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of ASA (when an appropriate PFO or small ASD defect is present) and rate of recurrent neurologic embolic event in patients with cryptogenic stroke and PFO
PFO Closure Rate
Suture Mediated PFO Closure and Septal Repair
Published PFO Device Closure
Suture Mediated PFO Closure and Septal Repair
Published PFO Device Closure
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PFO Closure Rate
Suture Mediated PFO Closure and Septal Repair
Published PFO Device Closure
Suture Mediated PFO Closure and Septal Repair
Interventions
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PFO Closure Rate
Suture Mediated PFO Closure and Septal Repair
Published PFO Device Closure
Suture Mediated PFO Closure and Septal Repair
Eligibility Criteria
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Inclusion Criteria
* ASD (less than 1 cm with redundant septal tissue)
* Trans Septal Puncture Sites
* ASA (when an appropriate PFO or small ASD defect is present)
* Stroke
* Trans ischemic Attack (TIA)
* Platypnea Orthodeoxia Syndrome
* Decompression Illness
Exclusion Criteria
* Patients who are not fluent in English
18 Years
65 Years
ALL
No
Sponsors
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HeartStitch.Com
INDUSTRY
Responsible Party
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James Thompson, MD
Interventional Cardiologist
Principal Investigators
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James Thompson, MD
Role: PRINCIPAL_INVESTIGATOR
Inova Cardiovascular Institute
Locations
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Inova Cardiovascular Institute
Falls Church, Virginia, United States
Countries
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Other Identifiers
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17-2871
Identifier Type: -
Identifier Source: org_study_id