Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study
NCT ID: NCT06078735
Last Updated: 2024-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2023-10-02
2024-12-31
Brief Summary
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Detailed Description
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Another method of vascular closure is the figure-of-eight (FoE) stitch - a subcutaneous suture that has been evaluated to achieve homeostasis following major cardiovascular procedures.
In recent years, invasive, vascular closure devices have become popular. However, results continue to suggest that the risk versus benefit has not been definitively demonstrated. Instead, the LockeT is a new suture retention device designed to closely mimic manual compression by distributing the tension of a FoE stitch over a larger surface area. In such a way, patients can have the benefits of MC without a healthcare professional to stand bedside.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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LockeT
These are the patients assigned for LockeT device arm to close the access site wound.
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.
Manual compression
These are the patients assigned for Manual Compression arm to close the access site wound.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Kansas City Heart Rhythm Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Dhanunjaya Lakkireddy, MD
Role: PRINCIPAL_INVESTIGATOR
Kansas City Heart Rhythm Institute
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Natale A, Mohanty S, Liu PY, Mittal S, Al-Ahmad A, De Lurgio DB, Horton R, Spear W, Bailey S, Bunch J, Musat D, O'Neill P, Compton S, Turakhia MP; AMBULATE Trial Investigators. Venous Vascular Closure System Versus Manual Compression Following Multiple Access Electrophysiology Procedures: The AMBULATE Trial. JACC Clin Electrophysiol. 2020 Jan;6(1):111-124. doi: 10.1016/j.jacep.2019.08.013. Epub 2019 Oct 30.
Mujer MT, Al-Abcha A, Flores J, Saleh Y, Robinson P. A comparison of figure-of-8-suture versus manual compression for venous access closure after cardiac procedures: An updated meta-analysis. Pacing Clin Electrophysiol. 2020 Aug;43(8):856-865. doi: 10.1111/pace.14008. Epub 2020 Jul 20.
Atti V, Turagam MK, Garg J, Alratroot A, Abela GS, Rayamajhi S, Lakkireddy D. Efficacy and safety of figure-of-eight suture versus manual pressure for venous access closure: a systematic review and meta-analysis. J Interv Card Electrophysiol. 2020 Apr;57(3):379-385. doi: 10.1007/s10840-019-00547-6. Epub 2019 Apr 18.
Jensen CJ, Schnur M, Lask S, Attanasio P, Gotzmann M, Kara K, Hanefeld C, Mugge A, Wutzler A. Feasibility of the Figure-of-8-Suture as Venous Closure in Interventional Electrophysiology: One Strategy for All? Int J Med Sci. 2020 Apr 6;17(7):965-969. doi: 10.7150/ijms.42593. eCollection 2020.
Other Identifiers
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KCHRRF_LockeT II_0023
Identifier Type: -
Identifier Source: org_study_id
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