Perclose Multi-Access Duplex Ultrasound (DUS) Study

Abbott

Status: Completed

Conditions: Arrhythmia

Treatments: Device: Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04904809

ABT-CIP-10410

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

All Registered Patients

Experimental group

Description:

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.

Treatment:

Device: Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System