Status:

UNKNOWN

Vascular Closure With Novel External Compression Device: The LockeT Study

Lead Sponsor:

Kansas City Heart Rhythm Research Foundation

Conditions:

Atrial Fibrillation

Hemostasis

Eligibility:

All Genders

18+ years

Brief Summary

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

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 t...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT06199414

Start Date

January 1 2024

End Date

December 1 2024

Last Update

January 10 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, United States, 66211

2

Overland Park Regional Medical Center

Overland Park, Kansas, United States, 66215