Comparison of Figure-Of-Eight Suture Perclose ProGlide Suture-Mediated Closure

January 9, 2023 updated by: Houman Khalili MD, Delray Medical Center

Comparison of Figure-Of-Eight Suture and Perclose ProGlide Suture-Mediated Closure System in Achieving Hemostasis After a Large Bore Venous Access.

The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Delray Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients who successfully undergo venous large bore access sheath placement for structural heart procedures.

Exclusion Criteria:

  • Patients who do not consent
  • Minors or those unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Figure-of-eight
Using the figure-of-eight closure technique when closing access for structural heart therapies.
Other: Figure-of-eight suture
Using the figure-of-eight closure technique when closing access for structural heart therapies.
Active Comparator: Perclose Device
Using the Perclose device when closing access for structural heart therapies.
Other: Perclose Device
Using the Perclose device when closing access for structural heart therapies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemostasis Time
Time Frame: Immediate
To assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access
Immediate
Procedure Time
Time Frame: Immediate
Immediate
Access Site Complication
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Delray Medical Center

Collaborators

Florida Atlantic University

Investigators

  • Principal Investigator: Houman Khalili, MD, Delray Medical Center
  • Principal Investigator: Brijeshwar Maini, Delray Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2020

Primary Completion (Actual)

December 13, 2022

Study Completion (Actual)

December 13, 2022

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-149

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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