Perclose Multi-Access Duplex Ultrasound (DUS) Study

Completed · Not applicable

Conditions studied: Arrhythmia

In brief

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 scheduled DUS at discharge and at 30 days (if vascular complications observed at discharge) in asymptomatic or non-visible subjects.

Key facts

Study ID

NCT04904809

Run by

Abbott Medical Devices

People needed

36

Starts

2021-09-01

Expected to finish

2022-05-27

Last updated by the study team

2023-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States
• St. Luke's Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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