Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Recruiting · NCT06078735 · Interventional (participants receive a specific treatment) · Lead sponsor: Kansas City Heart Rhythm Research Foundation
View the official record on ClinicalTrials.gov →Interventions studied
Vascular closure with LockeT device
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
6 locations listed across 2 US states.
- 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