November 12, 2021JACC. Clinical electrophysiology114 citationsOpen Access

Primary Results on Safety and Efficacy From the LEADLESS II–Phase 2 Worldwide Clinical Trial

VRVivek Y. Reddy DEDerek V. Exner RDRahul N. Doshi

Key Result

The re-designed Aveir single chamber leadless pacemaker was evaluated for safety and efficacy in a first-in-human phase 2 worldwide clinical trial.

Structured PICO

Does the re-designed Aveir single chamber leadless pacemaker provide safety and efficacy in a first-in-human clinical trial?

Population

Patients in the first-in-human experience of the LEADLESS II-Phase 2 Worldwide Clinical Trial

Intervention

Re-designed single chamber leadless pacemaker (Aveir)

Outcome

Safety and efficacysafety

The LEADLESS II-Phase 2 trial evaluates the safety and efficacy of the re-designed Aveir single chamber leadless pacemaker in a first-in-human worldwide study.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

A re-designed single chamber leadless pacemaker (LP; Aveir) was developed with the goal of improving safety and performance of its predecessor (Nanostim). Herein, we present the first-in-human expe...

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Cite This Study

Reddy et al. (Fri,) reported a other. The re-designed Aveir single chamber leadless pacemaker was evaluated for safety and efficacy in a first-in-human phase 2 worldwide clinical trial.

synapsesocial.com/papers/6a6c4033b1ab7113b2b3b08a https://doi.org/https://doi.org/10.1016/j.jacep.2021.11.002