Perclose Multi-Access Duplex Ultrasound (DUS) Study

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)

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmia
• Intervention / Treatment: Device: Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System

Detailed Description

This study is a prospective, single-arm, US multi-center, descriptive study to evaluate the safety of multiple access site closure in a single vein with the Perclose SMC. A total of 35 subjects will be registered at 2 US investigational sites. All subjects must have femoral DUS at discharge and at a 30-day follow-up visit (if any access site-related vascular complications (either symptomatic/visible or asymptomatic/nonvisible), nerve injury, or infection at discharge, by either the investigator or the core laboratory).

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Registered Patients; 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; 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

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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Reported Vascular Complications	Any vascular complications will also be analyzed as the descriptive endpoints. Vascular complications include but are not limited to: Femoral vein stenosis (> 50%) development at the puncture site related to closure technique; Deep vein thrombosis in the target limb; Venous bleeding, retroperitoneal bleeding; Venous access site injury including vessel laceration; Re-bleeding at the access site; Hematoma; Pseudoaneurysm; AV fistula; Venous tear; Venous perforation; Arterial tear; Arterial perforation; Infection; Non-flow limiting suture material; Access site-related nerve injury; Pulmonary embolism; Other (specify)	Procedure to 30 days Post Procedure
Procedure Duration	Length of time (in minutes) of procedure	Procedure
Type of procedure	Cryo-ablation, RF ablation, etc.	Procedure
Number of Femoral Vein Access Sites Per Subject	Number of Femoral Vein Access Sites Per Subject	Procedure
Number of Femoral Vein Access Sites Per Leg	Number of Femoral Vein Access Sites Per Leg	Procedure
Sheath Sizes Used	Sheath Sizes Used	Procedure
Total Number of Suture-Mediated Closure (SMC) Systems used	Total Number of SMC used	Procedure
Number of Suture Mediated-Closure (SMC) Systems used per closure procedure	Number of SMC used per closure procedure	Procedure
Number of Suture Mediated-Closure (SMC) Systems used per access site	Number of SMC used per access site • Number of SMC used for >8F access site	Procedure
Number of Suture Mediated-Closure (SMC) Systems used per leg	Number of SMC used per leg	Procedure
Device Success rate per access site	Successful hemostasis without surgical conversion, or additional non-study device (adjunctive manual compression and subcutaneous stitch are regarded as the standard of care and not included as failure)	Procedure
Anticoagulant and antiplatelet medications	Anticoagulant and antiplatelet medications used during the procedure	Procedure
Use of protamine for heparin reversal	Protamine used for heparin reversal	Procedure

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Sanjaya K Gupta, MD, St. Luke's Hospital; Principal Investigator: Soroosh Kiani, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): May 27, 2022

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Ablation; DUS; ABT-CIP-10410; Femoral DUS
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: ABT-CIP-10410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes