Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Oct;21(10):1914-1922.
doi: 10.1016/j.hrthm.2024.04.067. Epub 2024 May 17.

Safety, efficacy, and reliability evaluation ofa novel small-diameter defibrillation lead: Global LEADR pivotal trial results

George H Crossley 3rd  1 , Prashanthan Sanders  2 , Bert Hansky  3 , Paolo De Filippo  4 , Maully J Shah  5 , Morio Shoda  6 , Surinder Kaur Khelae  7 , Travis D Richardson  1 , François Philippon  8 , John S Zakaib  9 , Hung-Fat Tse  10 , Darius P Sholevar  11 , Christoph Stellbrink  12 , Rajeev K Pathak  13 , Goran Milašinović  14 , Jason S Chinitz  15 , Bernice Tsang  16 , Michael B West  17 , Brian M Ramza  18 , Xuebin Han  19 , Babak Bozorgnia  20 , Roberto Carta  21 , Tessa Geelen  22 , Adam K Himes  21 , Megan L Platner  21 , Amy E Thompson  21 , Pamela K Mason  23 ; Lead EvaluAtion for Defibrillation and Reliability Trial Investigators
Collaborators, Affiliations
Free article
Randomized Controlled Trial

Safety, efficacy, and reliability evaluation ofa novel small-diameter defibrillation lead: Global LEADR pivotal trial results

George H Crossley 3rd et al. Heart Rhythm. 2024 Oct.
Free article

Abstract

Background: Implantable cardioverter-defibrillators last longer, and interest in reliable leads with targeted lead placement is growing. The OmniaSecure defibrillation lead is a novel, small-diameter, catheter-delivered lead designed for targeted placement, based on the established SelectSecure SureScan MRI Model 3830 lumenless pacing lead platform.

Objective: This trial assessed safety and efficacy of the OmniaSecure defibrillation lead.

Methods: The worldwide LEADR pivotal clinical trial enrolled patients indicated for de novo implantation of a primary or secondary prevention implantable cardioverter-defibrillator or cardiac resynchronization therapy defibrillator, all of whom received the study lead. The primary efficacy end point was successful defibrillation at implantation per protocol. The primary safety end point was freedom from study lead-related major complications at 6 months. The primary efficacy and safety objectives were met if the lower bound of the 2-sided 95% credible interval was >88% and >90%, respectively.

Results: In total, 643 patients successfully received the study lead, and 505 patients have completed 12-month follow-up. The lead was placed in the desired right ventricular location in 99.5% of patients. Defibrillation testing at implantation was completed in 119 patients, with success in 97.5%. The Kaplan-Meier estimated freedom from study lead-related major complications was 97.1% at 6 and 12 months. The trial exceeded the primary efficacy and safety objective thresholds. There were zero study lead fractures and electrical performance was stable throughout the mean follow-up of 12.7 ± 4.8 months (mean ± SD).

Conclusion: The OmniaSecure lead exceeded prespecified primary end point performance goals for safety and efficacy, demonstrating high defibrillation success and a low occurrence of lead-related major complications with zero lead fractures.

Keywords: Cardiac arrhythmias therapy; Defibrillation leads; Implantable cardioverter-defibrillators; Ventricular fibrillation; Ventricular tachycardia.

PubMed Disclaimer

Conflict of interest statement

Disclosures G.H.C.: speaker at Medtronic and Philips; consultant for Medtronic and Boston Scientific. P.S.: reports having served on the advisory boards of Medtronic, Abbott, Boston Scientific, PaceMate, and CathRx; the University of Adelaide has received on his behalf lecture and/or consulting fees from Medtronic, Abbott, and Boston Scientific; and the University of Adelaide has received on his behalf research funding from Medtronic, Abbott, Boston Scientific, and Becton-Dickson. B.H.: reports funding from Medtronic and CVRx. P.D.F.: consultant fees and travel support from Medtronic, Boston Scientific, Abbott, and Biotronik as well as honoraria and advisory board participation for Medtronic, Abbott, and Biotronik. M.J.S.: consultant for Medtronic and Tenaya Therapeutics. M.S.: speaker honorarium from Medtronic Japan and financial endowments to our clinical research division from Biotronik Japan, Medtronic Japan, Boston Scientific Japan, and Abbott Japan. S.K.K.: member of the speakers bureau for Bayer/Schering Pharma, Boston Scientific, Medtronic, and Pfizer; speaker fees, honoraria, consultancy, advisory board fees, investigator, committee member for Novartis, Medtronic, Boehringer-Ingelheim, Boston Scientific, and Bayer. T.D.R.: consultant for Medtronic, Johnson and Johnson, and Philips; research funding from Medtronic and Abbott. F.P.: speaker at Medtronic and Boston Scientific; consultant for Medtronic and Boston Scientific; research funding from Medtronic and Boston Scientific. J.S.Z.: consultant for Medtronic. H.F.T.: consultant and speaker fee and research grant from Abbott, BMS/Pfizer, Bayer, Boehringer Ingelheim, Boston Scientific, Daiichi-Sankyo, Medtronic, and Sanofi. D.P.S.: institutional funding from Medtronic. C.S.: received scientific grants from Medtronic. R.K.P.: reports that Canberra Heart Rhythm Foundation has received on his behalf lecture and/or consulting fees from Medtronic, Abbott Medical, Boston Scientific, and Biotronik. G.M.: received honoraria from Medtronic. J.S.C.: consultant for Medronic, Biosense Webster, and Boston Scientific. B.T.: honorarium from Boston scientific. M.B.W.: consultant for Medtronic. B.M.R.: consultant for Medtronic. X.H.: consultant for Medtronic. B.B.: consultant for Medtronic. R.C., M.L.P., A.K.H., T.G, and A.E.T.: employees of Medtronic, Inc. P.K.M.: consultant for Medtronic, Boston Scientific, and Cook as well as honoraria from Medtronic and Cook.

Publication types

LinkOut - more resources