Status:
COMPLETED
Perclose Multi-Access Duplex Ultrasound (DUS) Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04904809
Start Date
September 1 2021
End Date
May 27 2022
Last Update
July 20 2023
Active Locations (2)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322
2
St. Luke's Hospital
Kansas City, Missouri, United States, 64111