First-in-Human Chronic Evaluation of Leadless Conduction System Pacing
Abbott Cardiac Rythm Management | April 25, 2026
Conduction system pacing (CSP), including left bundle branch area pacing (LBBAP), is increasingly used to preserve coordinated ventricular activation and ventricular synchrony. However, current CSP approaches rely on transvenous leads, exposing patients to the risks related to lead stability and durability and pocket-related infection. A novel investigational leadless pacemaker (AVEIR™ CSP) designed for conduction system pacing offers the potential to combine physiologic pacing with the benefits of a completely leadless system. This first-in‑human study evaluated the safety, feasibility, and short‑term performance of chronically implanted AVEIR CSP devices.
Patients with pacing indications received the AVEIR CSP system either as a standalone ventricular device or as part of a dual chamber leadless system paired with an atrial device. The primary safety endpoint was complications at one month, with secondary assessment of electrical performance and capture type, including LBBP, left ventricular septal pacing (LVSP), and deep septal pacing (DSP).
Of 20 enrolled patients, one was withdrawn due to challenging anatomy. Implantation was successful in 18 of 19 (95%) patients. At one month, electrical parameters remained within acceptable ranges (Figure 1). Capture at implant was classified as LBBP in 9 patients, LVSP in 5, and DSP in 4. In dual chamber systems, i2i™ communication remained stable through one month. The one month complication-free rate was 68.4%, with six patients experiencing adverse events, including internal jugular access hematoma, pericardial effusion, and device dislodgement or dislocation.
Figure 1:
Overall, this first-in‑human experience demonstrates that leadless conduction system pacing is feasible and can deliver acceptable short‑term electrical performance with functional dual chamber communication. However, device fixation stability and consistency of conduction system capture require further refinement.
Caution: Investigational Device. Limited by Federal (US) Law to Investigational use only. Not available for sale in the U.S.
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third-party trademark, which is property of its respective owner.
Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.
MAT-2630658 v2.0 | Item approved for U.S. use.