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RECRUITING
NCT06078735
NA

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

Sponsor: Kansas City Heart Rhythm Research Foundation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2023-10-02

Completion Date

2024-12

Last Updated

2024-10-29

Healthy Volunteers

No

Interventions

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 (6)

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, United States

Overland Park Regional Medical Center

Overland Park, Kansas, United States

Centerpoint Medical Center Clinic

Independence, Missouri, United States

Centerpoint Medical Center

Independence, Missouri, United States

Research Medical Center Clinic

Kansas City, Missouri, United States

Research Medical Center

Kansas City, Missouri, United States