Actively Recruiting
Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Led by Kansas City Heart Rhythm Research Foundation · Updated on 2024-10-29
110
Participants Needed
6
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be at least 18 years of age
- Able to provide consent
- Scheduled for planned procedures requiring percutaneous venous punctures, such as atrial fibrillation radiofrequency ablation, where LockeT or manual compression will be used to close the wound
You will not qualify if you...
- Under 18 years of age
- Unable or unwilling to provide consent
- Unable to comply with study requirements
- Not undergoing procedures requiring percutaneous venous puncture or planned access to left atrium or ventricle
- Physician does not use LockeT or manual compression to close venous puncture
- Currently pregnant, as shown by positive urine Beta-HCG test
- Presence of a formed hematoma before venous closure
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, United States, 66211
Actively Recruiting
2
Overland Park Regional Medical Center
Overland Park, Kansas, United States, 66215
Actively Recruiting
3
Centerpoint Medical Center Clinic
Independence, Missouri, United States, 64057
Actively Recruiting
4
Centerpoint Medical Center
Independence, Missouri, United States, 64057
Actively Recruiting
5
Research Medical Center Clinic
Kansas City, Missouri, United States, 64032
Actively Recruiting
6
Research Medical Center
Kansas City, Missouri, United States, 64032
Actively Recruiting
Research Team
D
Donita Atkins
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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