Safety and performance of a novel defibrillation lead for left bundle branch area placement: Primary results of the LEADR LBBAP clinical trial
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Right ventricular placement of the OmniaSecure defibrillation lead has demonstrated high defibrillation success and low occurrence of lead-related major complications. With the advent of left bundle branch area pacing (LBBAP) as a physiological pacing option, the use of the OmniaSecure lead may be a viable alternative for LBBAP in the implantable cardioverter-defibrillator population. OBJECTIVE: This study aimed to understand the defibrillation efficacy at implant and the safety of the OmniaSecure lead for LBBAP. METHODS: The global Lead Evaluation for Defibrillation and Reliability LBBAP trial enrolled patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator or cardiac resynchronization therapy with a defibrillator. Per study protocol, LBBAP includes electrocardiographic characterization of left bundle branch pacing and deep septal pacing. The primary efficacy objective was defibrillation efficacy at implant exceeding a prespecified threshold of 88% in ≥160 patients. The primary safety endpoint was to demonstrate the OmniaSecure lead-related major complication rate at 3 months after implant. RESULTS: ). A total of 293 patients were successfully implanted per protocol (95.4%). The primary efficacy objective was met with 100% of patients defibrillated to protocol. The observed freedom from OmniaSecure lead-related major complications at 3 months was 97.9% (95% confidence interval 95.8-100). There were zero study lead fractures, no oversensing adverse events, and stable electrical parameters through 2.6 ± 2.5 months' follow-up. CONCLUSION: These results demonstrate that implantation of OmniaSecure lead when intended for LBBAP results in high defibrillation success at implant, stable short-term electrical parameters, and a low rate of OmniaSecure lead-related major complications at 3 months.
Source: Heart Rhythm
Authors: Pugazhendhi Vijayaraman, Xingbin Liu, Russell Denman, Edward J. Schloss, Zachary I. Whinnett, Jordana Kron, Marek Jastrzębski, John S. Zakaib, Walter P. Abhayaratna, François Philippon, Muhammad R. Afzal, Parash Pokharel, James Burrell, Jocelyn Tanner, Tessa Geelen, Megan L. Platner, Kiah Butler, Pamela K. Mason, George H. Crossley
Institutions: Geisinger Wyoming Valley Medical Center, Sichuan University, West China Hospital of Sichuan University, Prince Charles Hospital, Christ Hospital, Imperial College Healthcare NHS Trust, Imperial College London, Virginia Commonwealth University, Jagiellonian University, Minneapolis Heart Institute Foundation, Canberra Hospital, ACT Government, Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval, The Ohio State University Wexner Medical Center, Medtronic (United States), Medtronic (Netherlands), University of Virginia Medical Center, Vanderbilt University, Vanderbilt Health
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,790
OpenAlex ID: W4415321908