Vascular Closure With a Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study

Atrial Fibrillation Clinical Trial

Official title:

Vascular Closure With Novel Ergonomic External Compression Device Compared to Manual Compression After Atrial Fibrillation Ablation: The LockeT II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078735
• Other study ID #: KCHRRF_LockeT II_0023
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 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: Interventional

Clinical Trial 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.

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 decrease in complication rates due to refinement in ablation tools and techniques, achieving vascular hemostasis following large-bore sheath femoral access remains a challenge. Thus, MC remains the current standard of care. However, MC requires up to 8 hours of prolonged bedrest, which is associated with longer length of stay and complications from indwelling catheters.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hemostasis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Centerpoint Medical Center	Independence	Missouri
United States	Centerpoint Medical Center Clinic	Independence	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Research Medical Center Clinic	Kansas City	Missouri
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 using the LockeT suture retention device	Effectiveness of using the LockeT suture retention device to gain hemostasis after venous procedures as compared to standard Manual Compression (MC) will be assessed.	2 Days
Secondary	Patient, physician, and nursing staff benefits	Patient, physician, and nursing staff benefits of the LockeT device will be assessed via LockeT device questionnaire with a scale of 1 to 5, 1 strongly disagree and 5 strongly agree.	2 Days
Secondary	Patient discomfort with Locket device	Pain discomfort will be assessed via Locket device questionnaire with a scale of 1 to 5, 1 strongly disagree and 5 strongly agree.	2 Days
Secondary	Incidence of hematoma/ecchymosis	The incidence of hematoma/ecchymosis post-procedure will be assessed.	2 Days
Secondary	Safety of LockeT device	Safety of LockeT device will be assessed by the incidence of adverse events, including but not limited to: vascular complications, like atrioventricular (AV) fistula, retroperitoneal bleed, surgical exploration of the groin (thrombin injection, open surgery or ligation); need for blood transfusion, defined as a 2 gm post-procedure drop in hemoglobin, or symptoms of anemia,).	2 Days
Secondary	Comparison of Manual Compression labor cost and Locket device cost	Manual Compression labor cost and Locket device cost will be compared	2 Days