Vascular Closure With Novel External Compression Device: The LockeT Study

December 29, 2023 updated by: Kansas City Heart Rhythm Research Foundation

Vascular Closure With Novel External Compression Device After Atrial Fibrillation Ablation: The LockeT Study

Single center, retrospective review study comparing Figure of Eight suture to LockeT, enrolling approximately 70 patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The volume of catheter ablation procedures for the treatment of atrial fibrillation and other arrhythmias are on the rise in the United States and worldwide. Despite refinement in ablation tools and techniques which has led to a significant decline in complication rates, achieving vascular hemostasis following femoral access with large bore sheaths remains a challenge. Manual compression (MC) the current standard of care, requires bedrest, often up to 8 hours. This prolonged bedrest is associated with longer length of stay and at times complications from indwelling catheters.

Other methods of vascular closure include figure-of-eight (F-8) a, subcutaneous suture or Z-stitch or fellow's stitch has been evaluated as a means to achieve homeostasis following major cardiovascular procedures. One pooled meta-analysis of six studies including 982 patients demonstrated that F-8 is safe and effective means of achieving hemostasis. In comparison to MC time to hemostasis was significantly lower and overall access site complications like hematoma, bleeding was also noted to be lower in F-8 group.

In recent years, invasive, vascular closure devices have become popular. However, results continue to suggest that the risk versus benefit has not been definitively demonstrated. LockeT is a new suture retention device designed to closely mimic manual compression without the need for a healthcare professional to stand bedside.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Overland Park Regional Medical Center
        • Contact:
          • Donita Atkins
      • Overland Park, Kansas, United States, 66211
        • Kansas City Heart Rhythm Institute - Roe Clinic

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include who underwent AF ablation and required F-8 or LockeT post procedure.

Description

Inclusion Criteria:

All participants must meet the following criteria to be included in this study.

  • Subjects must be at least 18 years of age.
  • Subjects underwent Atrial Fibrillation radiofrequency ablation procedure.
  • Subjects must have undergone F-8 or LockeT for venous closure.

Exclusion Criteria:

If a subject meet any of the following criteria will be excluded from study participation.

  • Subjects under the age of 18.
  • Subject's electrophysiology procedure is not planned to access the left atrium or ventricle.
  • Subjects in which F-8 or a LockeT was not used.
  • If the EP physician detected a formed hematoma prior to venous closure, that patient will be excluded from the study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with Figure-of-eight (F-8) suture
This is the group of subjects for whom Figure-of-eight (F-8) suture is used for their venous closure.
Device: Venous Closure
Vascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures
Subjects with LockeT Device
This is the group of subjects for whom LockeT device is used for their venous closure.
Device: Venous Closure
Vascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of LockeT device - Time to no oozing/hemostasis
Time Frame: 1 week

To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures.

Time to no oozing/hemostasis (mins/hours)
1 week
Effectiveness of LockeT device - Time to Ambulate
Time Frame: 1 week

To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures.

Time to no oozing/hemostasis (mins/hours)
1 week

Collaborators and Investigators

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

Sponsor

Kansas City Heart Rhythm Research Foundation

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

January 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 29, 2023

First Submitted That Met QC Criteria

December 29, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCHRRF_LockeT Retrospect_0020

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.

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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