Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Recruiting now · Not applicable
Conditions studied: Atrial Fibrillation, Hemostasis
In brief
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.
Key facts
- Study ID
- NCT06078735
- Run by
- Kansas City Heart Rhythm Research Foundation
- People needed
- 110
- Starts
- 2023-10-02
- Expected to finish
- 2024-12-01
- Last updated by the study team
- 2024-10-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Kansas City Heart Rhythm Institute - Roe Clinic — Overland Park, Kansas, United States (enrolling)
- Overland Park Regional Medical Center — Overland Park, Kansas, United States (enrolling)
- Centerpoint Medical Center Clinic — Independence, Missouri, United States (enrolling)
- Centerpoint Medical Center — Independence, Missouri, United States (enrolling)
- Research Medical Center Clinic — Kansas City, Missouri, United States (enrolling)
- Research Medical Center — Kansas City, Missouri, United States (enrolling)
Full record on ClinicalTrials.gov
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