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

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital, Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System

Device

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 names: Perclose ProStyle SMCR System

Primary outcomes

Number of Subjects With Major Vascular Complications by DUS Detection at Discharge

Time frame: Within 24 hours of procedure.

Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. Major complications are defined as those which require surgical, interventional, or pre-specified repair and/or hospitalization.
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge

Time frame: Within 24 hours of procedure.

Vascular complications detected by scheduled DUS at discharge in subjects with asymptomatic/non-visible complications. All complications other than Major complications are considered to be minor complications.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Perclose Multi-Access DUS Study: Assess the Safety and Performance of the Perclose ProGlide™ Suture-Mediated Closure (SMC) System and the Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System in Managing Multiple Venous Access Sites (Evaluation by DUS)

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: May 27, 2021
Registry last updated: Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed