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Perclose Multi-Access Duplex Ultrasound (DUS) Study

Primary Purpose

Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmia focused on measuring ABT-CIP-10410, Ablation, DUS, Femoral DUS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Emory University Hospital
  • St. Luke's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Registered Patients

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 18, 2021
Last Updated
July 19, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT04904809
Brief Title
Perclose Multi-Access Duplex Ultrasound (DUS) Study
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
May 27, 2022 (Actual)
Study Completion Date
May 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
ABT-CIP-10410, Ablation, DUS, Femoral DUS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Registered Patients
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
Other Intervention Name(s)
Perclose ProStyle SMCR System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Subjects With Major Vascular Complications by DUS Detection at Discharge
Description
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.
Time Frame
Within 24 hours of procedure.
Title
Number of Subjects With Minor Vascular Complications by DUS Detection at Discharge
Description
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.
Time Frame
Within 24 hours of procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjaya K Gupta, MD
Organizational Affiliation
St. Luke's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soroosh Kiani, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Perclose Multi-Access Duplex Ultrasound (DUS) Study

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