Vascular Closure With Novel External Compression Device: The LockeT Study

Atrial Fibrillation Clinical Trial

Official title:

Vascular Closure With Novel External Compression Device After Atrial Fibrillation Ablation: The LockeT Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06199414
• Other study ID #: KCHRRF_LockeT Retrospect_0020
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Single center, retrospective review study comparing Figure of Eight suture to LockeT, enrolling approximately 70 patients.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hemostasis

Intervention

Device:
• Venous Closure
Vascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures

Locations

Country	Name	City	State
United States	Kansas City Heart Rhythm Institute - Roe Clinic	Overland Park	Kansas
United States	Overland Park Regional Medical Center	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of LockeT device - Time to no oozing/hemostasis	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
Primary	Effectiveness of LockeT device - Time to Ambulate	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