Study Results
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View full resultsBasic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2021-09-01
2022-05-27
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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All Registered Patients
All registered patients will have multiple access sites in a single vein closed utilizing the Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System.
Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.
Interventions
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Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
The Perclose ProGlide SMC and Perclose ProStyle SMCR in this study will be used for multiple access site closures in a single vein in the ablation procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is planned to have an ablation procedure that requires multiple sheaths insertion in a single femoral vein
* All the access sites are planned to be treated with Perclose SMC
* Written informed consent is obtained prior to the procedure
Exclusion Criteria
* Prior ipsilateral deep vein thrombosis within 6 months
* International Normalization Ratio \>3.5 for patients on warfarin
* Subject who is not able to ambulate pre-procedure
* Women who are pregnant (based on site standard pre-procedure pregnancy test)
* Has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Sanjaya K Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Hospital
Soroosh Kiani, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital
Atlanta, Georgia, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ABT-CIP-10410
Identifier Type: -
Identifier Source: org_study_id
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