Arrhythmias & electrophysiology

Pacing Performance of a Modular Communicative Leadless Pacing-Defibrillator System

EuropacePublished ongoing trial

Authors' conclusion

The performance of the modular pacing-defibrillator system at one year demonstrated a low complication rate and reliable pacing functionality.

Study context

Population
Patients with an ICD indication and at high risk for monomorphic ventricular tachycardia; pacemaker dependent patients were excludedLeadless pacemaker (LP) implant was attempted in 286 patients
Participants
297 patients
Outcome
Primary safety endpoint 2: percentage of patients free from major LP-related complications
Follow-up
12 months

Main finding

As reported in the abstract

Major LP-related complication free rate

97.2%

one-sided 97.5% LCL 94.5%

Further findings

Baseline characteristics

Mean age
59±12 years
Mean left ventricular ejection fraction
35.3±13.1%
Female
17.5%

LP implant success

LP implant successful, of 286 patients in whom it was attempted
100%

Secondary effectiveness endpoint: rate response performance of the LP under workload (slope of the normalized sensor rate versus the normalized workload)

Slope of the normalized sensor rate versus the normalized workload
0.96 (95% LCL 0.91, 95% UCL 1.02)
  • Within the performance goal range of 0.65-1.35

Pacing capture threshold ≤ 2V @ 0.4ms pulse width · 12 months

Patients with a pacing capture threshold ≤ 2V @ 0.4ms pulse width
96.8%

Safety

There were no LP-related complications following Implant

Original publication

Pacing Performance of a Modular Communicative Leadless Pacing-Defibrillator System. Europace. Published 5 November 2026. doi:10.1093/europace/euag309

Composed by AI from the published abstract and checked against it. How Briefs are made →

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