RecruitingNot ApplicableNCT06078735

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

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

Sponsor

Kansas City Heart Rhythm Research Foundation

Enrollment

110 participants

Start Date

Oct 2, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Hemostasis

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (LockeT II) is comparing two methods of closing the puncture site in the groin veins after a heart procedure for atrial fibrillation (AF ablation): using a special closure device (LockeT) versus pressing on the area manually (manual compression). The goal is to find the safest and most comfortable approach. **You may be eligible if...** - You are at least 18 years old - You can provide informed consent - You are scheduled for a vein-based heart procedure such as atrial fibrillation ablation where either the LockeT device or manual compression is used **You may NOT be eligible if...** - You are under 18 years old - You are unable or unwilling to provide consent - You cannot comply with the follow-up requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVascular 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.