Arrhythmias & electrophysiology

Safety and Efficacy of the Novel OmniaSecure Defibrillation Lead Through Long-Term Follow-Up: Final Results From the LEADR Trial

Circ Arrhythm ElectrophysiolPublished Single-arm clinical trial

Authors' conclusion

The 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.

Study context

Population
Patients with an indication for de novo ICD/CRT defibrillator643 (97.9%) successfully implanted
Participants
657 patients
Outcome
Freedom from major study lead-related complications
Follow-up
3 years
Methodological detailsprospective, multicentre
  • Prospective
  • Multicentre

Main finding

As reported in the abstract

Freedom from major study lead-related complications at 3 years

96.5%

Observational data: associations, not effects.

Further findings

Appropriate therapies (shock and ATP) · 3 years

Patients receiving appropriate therapies
22.3%
Antitachycardia pacing efficacy
75.4%

Pacing capture threshold, pacing impedance, R-wave amplitudes

Remained stable throughout

Safety

Inappropriate shock rate at 1 year
2.7%
Inappropriate shock rate at 3 years
5.9%

Original publication

Safety and Efficacy of the Novel OmniaSecure Defibrillation Lead Through Long-Term Follow-Up: Final Results From the LEADR Trial. Circ Arrhythm Electrophysiol. Published 12 November 2025. doi:10.1161/circep.125.014424

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