Vascular Closure With Novel External Compression Device: The LockeT Study

Launched by KANSAS CITY HEART RHYTHM RESEARCH FOUNDATION · Dec 29, 2023

Keywords

ClinConnect Summary

The LockeT Study is a clinical trial that is looking at two different methods for closing veins after a specific heart procedure called Atrial Fibrillation radiofrequency ablation. The two methods being compared are a traditional stitch method known as the Figure of Eight (F-8) suture and a new device called LockeT. This study will involve about 70 patients and aims to find out which method is more effective for ensuring proper healing after the procedure.

To participate in this trial, individuals must be at least 18 years old and have undergone the Atrial Fibrillation procedure where either the F-8 suture or the LockeT device was used to close the vein. Unfortunately, those under 18, those whose procedure did not involve reaching the left side of the heart, or those who had any issues like a blood clot before the closure will not be included. While the study is not yet open for recruiting participants, those who take part can expect to contribute to important research that may help improve recovery methods for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.