Trial reportCirculation. Arrhythmia and electrophysiology2026
Safety and Efficacy of the Novel OmniaSecure Defibrillation Lead Through Long-Term Follow-Up: Final Results From the LEADR Trial.
Trial report in Circulation. Arrhythmia and electrophysiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07406737 (Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Conduction system pacing for cardiac resynchronization therapy: a systematic review.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026Pooled it
- Transvenous Lead Extraction Using Mechanical Rotational Dilator Sheaths: A 19-Year Single-Center Experience from a Pediatric Cardiology Center.Journal of cardiovascular development and disease · 2026Article
- Left Bundle Branch Area Antitachycardia Pacing Improves Success Rate Compared to Right Ventricular Antitachycardia Pacing.JACC. Clinical electrophysiology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe LEADR (Lead Evaluation for Defibrillation and Reliability) trial evaluated the small-diameter (4.7F), lumenless, integrated bipolar OmniaSecure defibrillation lead. The trial exceeded primary safety and efficacy objective thresholds, demonstrating favorable efficacy at implant and a low rate of complications. Three-year term outcomes of the LEADR trial assessing the OmniaSecure lead are reported here.
methodsThe LEADR trial is a prospective, multicenter, single-arm clinical trial. Patients with an indication for de novo implantable cardioverter defibrillator/cardiac resynchronization therapy defibrillator were implanted with the OmniaSecure lead in standard right ventricle locations and followed at prespecified intervals. The lead was evaluated for safety, efficacy, and reliability through final follow-up.
resultsThere were 643/657 patients (97.9%) successfully implanted with the OmniaSecure lead with a mean follow-up of 32.4±9.1 months (26% female, 61.9±12.9 years). Pacing capture threshold, pacing impedance, and R-wave amplitudes remained stable throughout. There was a 96.5% freedom from major study lead-related complications at 3 years. At 3 years, 22.3% of patients received appropriate therapies, that is, shock and antitachycardia pacing, with a 75.4% antitachycardia pacing efficacy. Inappropriate shock rate was 2.7% and 5.9% at 1 and 3 years, respectively.
conclusionsThe final results of the LEADR trial demonstrated 3-year term safety, efficacy, and reliability of the OmniaSecure lead, emphasizing the potential utility of this lead in a wide variety of patients.
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