Perclose Multi-Access Duplex Ultrasound (DUS) Study

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

Official 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)

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Device: Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Registered Patients<br>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. | Device: Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System<br>* 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.<br>* Other names: Perclose ProStyle SMCR System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Major Vascular Complications by DUS Detection at Discharge | 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. | Within 24 hours of procedure. | 
| Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge | 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. | Within 24 hours of procedure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ABT-CIP-10410, Ablation, DUS, Femoral DUS