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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKansas City Heart Rhythm Research Foundation

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Vascular closure with LockeT device

Treatment groups

110 Participants
are divided into 2 treatment groups

Locations

6
Kansas City Heart Rhythm Institute - Roe Clinic66211, Overland ParkKansas, United States
Overland Park Regional Medical Center66215, Overland ParkKansas, United States
Centerpoint Medical Center64057, IndependenceMissouri, United States
Centerpoint Medical Center Clinic64057, IndependenceMissouri, United States

Sponsors and collaborators

Kansas City Heart Rhythm Research Foundation

Lead sponsor