Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study

Description

The LockeT II study is a single center, prospective randomized study. It is intended to study the effectiveness of using LockeT device to gain hemostasis after venous procedures as compared to Manual Compression (MC). Approximately 110 patients will be enrolled.

Conditions

Atrial Fibrillation, Hemostasis

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Study Overview

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Study Details

Study overview

The LockeT II study is a single center, prospective randomized study. It is intended to study the effectiveness of using LockeT device to gain hemostasis after venous procedures as compared to Manual Compression (MC). Approximately 110 patients will be enrolled.

Vascular Closure With Novel Ergonomic External Compression Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study

Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study

Condition
Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Overland Park

Kansas City Heart Rhythm Institute - Roe Clinic, Overland Park, Kansas, United States, 66211

Overland Park

Overland Park Regional Medical Center, Overland Park, Kansas, United States, 66215

Independence

Centerpoint Medical Center Clinic, Independence, Missouri, United States, 64057

Independence

Centerpoint Medical Center, Independence, Missouri, United States, 64057

Kansas City

Research Medical Center Clinic, Kansas City, Missouri, United States, 64032

Kansas City

Research Medical Center, Kansas City, Missouri, United States, 64032

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Must be at least 18 years of age
  • * Be able to provide consent
  • * Presenting for planned procedures that require percutaneous venous punctures, such as atrial fibrillation radiofrequency ablation, and where the physician utilizes a LockeT device or MC to close the wound.
  • * Under the age of 18
  • * Unable to or unwilling to provide consent
  • * Cannot comply with study requirements
  • * Not undergoing procedures that require a percutaneous venous puncture or planned access to the left atrium and/or ventricle
  • * Subjects whose physician does not use LockeT or MC to close the venous puncture.
  • * Patient is currently pregnant, as evidenced by positive urine Beta-HCG. (Urine Beta Human chorionic gonadotropin (HCG) will be checked in all females of the reproductive age group).
  • * If the physician detects a formed hematoma prior to venous closure, that patient will be excluded from the study.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kansas City Heart Rhythm Research Foundation,

Dhanunjaya Lakkireddy, MD, PRINCIPAL_INVESTIGATOR, Kansas City Heart Rhythm Institute

Study Record Dates

2024-12