Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Vascular Closure With Novel Ergonomic External Compression Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
Kansas City Heart Rhythm Research Foundation
110 participants
Oct 2, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria7
- 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.
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT06078735