Vascular Closure With Novel External Compression Device: The LockeT Study

NCT06199414 | Unknown FDA Device

• 1 other identifier: KCHRRF_LockeT Retrospect_0020
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Atrial Fibrillation; Hemostasis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

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.

Device: Venous Closure

Subjects with LockeT Device

This is the group of subjects for whom LockeT device is used for their venous closure.

Device: Venous Closure

Interventions

Venous Closure DEVICE

Vascular closure to achieve vascular hemostasis following femoral access with large bore sheaths in catheter ablation procedures

Subjects with Figure-of-eight (F-8) suture; Subjects with LockeT Device

Eligibility Criteria

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

Study Population

The study population will include who underwent AF ablation and required F-8 or LockeT post procedure.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead

Study Sites (2)

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, 66211, United States

Location

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

Location

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: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 10, 2024
• Study Start: January 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 10, 2024

Record last verified: 2023-12

Locations

US (2)