Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.

Launched by UNIVERSITY OF MASSACHUSETTS, WORCESTER · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing two methods to close the body after implanting a leadless pacemaker, which is a device that helps control heart rhythm. The study will look at whether using a special suture technique (called percutaneous suture-mediated closure) is better than a simpler method of using a stitch (known as a figure-of-eight suture) for closing the vein where the pacemaker was placed.

To be eligible for this trial, participants need to be at least 18 years old and scheduled for a leadless pacemaker implant at UMass Chan Medical Center. They must also be able to understand the study and provide written consent. Unfortunately, pregnant individuals and those who cannot walk before the procedure, along with others who may face risks, cannot participate. Those who join the trial can expect to receive one of the two closure methods after their pacemaker is implanted, and the study aims to find out which method works better for healing.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 18 and older
• • Patients undergoing leadless pacemaker implant at UMass Chan Medical Center
• • Subjects able to understand and provide written informed consent.
• Exclusion Criteria:
• • Patients who are pregnant
• • Patents who are not able to ambulate prior to the procedure
• • Other conditions that, in the opinion of the investigator constitute a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
• • Prisoners or wards of the state.