Vascular Closure With Novel External Compression Device: The LockeT Study
Vascular Closure With Novel External Compression Device After Atrial Fibrillation Ablation: The LockeT Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The volume of catheter ablation procedures for the treatment of atrial fibrillation and other arrhythmias are on the rise in the United States and worldwide. Despite refinement in ablation tools and techniques which has led to a significant decline in complication rates, achieving vascular hemostasis following femoral access with large bore sheaths remains a challenge. Manual compression (MC) the current standard of care, requires bedrest, often up to 8 hours. This prolonged bedrest is associated with longer length of stay and at times complications from indwelling catheters.
Other methods of vascular closure include figure-of-eight (F-8) a, subcutaneous suture or Z-stitch or fellow's stitch has been evaluated as a means to achieve homeostasis following major cardiovascular procedures. One pooled meta-analysis of six studies including 982 patients demonstrated that F-8 is safe and effective means of achieving hemostasis. In comparison to MC time to hemostasis was significantly lower and overall access site complications like hematoma, bleeding was also noted to be lower in F-8 group.
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. LockeT is a new suture retention device designed to closely mimic manual compression without the need for a healthcare professional to stand bedside.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Donita Atkins
- Phone Number: 816-651-1969
- Email: datkins@kchrf.com
Study Locations
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Kansas
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Overland Park, Kansas, United States, 66215
- Overland Park Regional Medical Center
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Contact:
- Donita Atkins
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Overland Park, Kansas, United States, 66211
- Kansas City Heart Rhythm Institute - Roe Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
All participants must meet the following criteria to be included in this study.
- Subjects must be at least 18 years of age.
- Subjects underwent Atrial Fibrillation radiofrequency ablation procedure.
- Subjects must have undergone F-8 or LockeT for venous closure.
Exclusion Criteria:
If a subject meet any of the following criteria will be excluded from study participation.
- Subjects under the age of 18.
- Subject's electrophysiology procedure is not planned to access the left atrium or ventricle.
- Subjects in which F-8 or a LockeT was not used.
- If the EP physician detected a formed hematoma prior to venous closure, that patient will be excluded from the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Subjects with Figure-of-eight (F-8) suture
This is the group of subjects for whom Figure-of-eight (F-8) suture is used for their venous closure.
|
Vascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures
|
|
Subjects with LockeT Device
This is the group of subjects for whom LockeT device is used for their venous closure.
|
Vascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of LockeT device - Time to no oozing/hemostasis
Time Frame: 1 week
|
To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures. Time to no oozing/hemostasis (mins/hours) |
1 week
|
|
Effectiveness of LockeT device - Time to Ambulate
Time Frame: 1 week
|
To assess the effectiveness of using LockeT to retain sutures and pressure to gain hemostasis after venous procedures. Time to no oozing/hemostasis (mins/hours) |
1 week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCHRRF_LockeT Retrospect_0020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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