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

NCT06078735 | Recruiting FDA Device

• 1 other identifier: KCHRRF_LockeT II_0023
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Atrial Fibrillation; Hemostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient, physician, and nursing staff benefits

  2 Days

• Patient discomfort with Locket device

  2 Days

• Incidence of hematoma/ecchymosis

  2 Days

• Safety of LockeT device

  2 Days

• Comparison of Manual Compression labor cost and Locket device cost

  2 Days

Study Arms (2)

LockeT

EXPERIMENTAL

These are the patients assigned for LockeT device arm to close the access site wound.

Device: Vascular closure with LockeT device

Manual compression

NO INTERVENTION

These are the patients assigned for Manual Compression arm to close the access site wound.

Interventions

Vascular closure with LockeT device 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.

LockeT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead

Study Sites (6)

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, 66211, United States

RECRUITING

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

RECRUITING

Centerpoint Medical Center Clinic

Independence, Missouri, 64057, United States

RECRUITING

Centerpoint Medical Center

Independence, Missouri, 64057, United States

RECRUITING

Research Medical Center Clinic

Kansas City, Missouri, 64032, United States

RECRUITING

Research Medical Center

Kansas City, Missouri, 64032, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 31971899 BACKGROUND

• 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.

  PMID: 32638389 BACKGROUND

• 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.

  PMID: 31001767 BACKGROUND

• 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.

  PMID: 32308550 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dhanunjaya Lakkireddy, MD

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969; Datkins@kchrf.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized 1:1 to LockeT device or Manual Compression.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 12, 2023
• Study Start: October 2, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

US (6)