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COMPLETEDNANCT04904809

Perclose Multi-Access Duplex Ultrasound (DUS) Study

The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by s...

Lead sponsor: Abbott Medical Devices•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Abbott Medical Devices

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Age ≥18 years
•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

•Visible vascular thrombus (angiographic or ultrasound) in the ipsilateral leg prior to the ablation procedure
•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 20, 2023Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment36

Start dateSep 2021

Last updatedJul 20, 2023

Condition

Locations shown

Emory University Hospital

Atlanta, Georgia

St. Luke's Hospital

Kansas City, Missouri

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2023Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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