Status:
RECRUITING
Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Lead Sponsor:
Kansas City Heart Rhythm Research Foundation
Conditions:
Atrial Fibrillation
Hemostasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
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 decrease in complication rates due...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06078735
Start Date
October 2 2023
End Date
December 1 2024
Last Update
October 29 2024
Active Locations (6)
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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
3
Centerpoint Medical Center Clinic
Independence, Missouri, United States, 64057
4
Centerpoint Medical Center
Independence, Missouri, United States, 64057