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Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Sponsor: Kansas City Heart Rhythm Research Foundation
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 Compression (MC). Approximately 110 patients will be enrolled.
Official title: Vascular Closure With Novel Ergonomic External Compression Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2023-10-02
Completion Date
2024-12
Last Updated
2024-10-29
Healthy Volunteers
No
Conditions
Interventions
Vascular closure with LockeT device
For subjects that are assigned to the LockeT device arm, the healthcare professional will place the LockeT with suture above the wound to achieve compression instead of manually holding pressure on the sutures. After hemostasis is achieved and prior to ambulation the LockeT will be removed followed by suture removal.
Locations (6)
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
Centerpoint Medical Center Clinic
Independence, Missouri, United States
Centerpoint Medical Center
Independence, Missouri, United States
Research Medical Center Clinic
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States