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Multicenter Study
. 2025 Apr;18(4):e013619.
doi: 10.1161/CIRCEP.124.013619. Epub 2025 Mar 27.

One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker

Reinoud E Knops  1 , James E Ip  2 , Rahul Doshi  3 , Derek V Exner  4 , Pascal Defaye  5 , Robert Canby  6 , Maria Grazia Bongiorni  7 , Morio Shoda  8 , Gerhard Hindricks  9 , Petr Neužil  10 , Mayer Rashtian  11 , Karel T N Breeman  1 , Jordan R Nevo  12 , Leonard Ganz  12 , Chris Hubbard  12 , Anu Bulusu  12 , Vivek Y Reddy  10   13
Affiliations
Multicenter Study

One-Year Safety and Performance of a Dual-Chamber Leadless Pacemaker

Reinoud E Knops et al. Circ Arrhythm Electrophysiol. 2025 Apr.

Abstract

Background: A dual-chamber leadless pacemaker can provide bradycardia therapy to most patients with pacemaker indications without the complications associated with a lead or pulse generator. We sought to confirm whether previously reported 3-month safety and performance outcomes were sustained through 12 months by determining whether 12-month complication-free and performance success rates exceeded their prespecified performance goals.

Methods: Patients were enrolled in the prospective, single-group Aveir DR i2i Study if they had a standard indication for dual-chamber pacing. Enrolled patients were implanted with an Aveir DR dual-chamber leadless pacemaker system, which comprised 2 communicating leadless pacemakers (1 in the right atrium and 1 in the right ventricle). The primary safety outcome evaluated whether freedom from serious device- or procedure-related events through 365 days exceeded the predetermined performance goal of 76.5%. The primary performance outcome determined whether the composite of atrial capture threshold (≤3.0 V at 0.4 ms) and sensing amplitude (P-wave ≥1.0 mV) at the 12-month visit exceeded the predetermined performance goal of 80.0%.

Results: Sites attempted implantation in 300 subjects, where 63.3% had sinus-node dysfunction and 33.3% had atrioventricular block as their primary pacing indication. The primary safety end point was achieved, with a Kaplan-Meier 12-month complication-free rate of 88.6% (95% CI, 84.5-91.8; P<0.001). The primary performance end point was achieved in 92.8% of patients (95% CI, 89.7-95.8; P<0.001).

Conclusions: Both primary safety and performance end points were met after 1 year, demonstrating consistency with previously reported 3-month outcomes of a dual-chamber leadless pacemaker.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05252702.

Keywords: bradycardia; goals; heart atria; heart ventricles; humans; pacemaker, artificial.

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Conflict of interest statement

Dr Knops is a consultant for Abbott, Boston Scientific, and Medtronic and receives institutional research grants from Abbott and Boston Scientific. Dr Canby is a consultant for Medtronic. Dr Defaye receives institutional research grants from Abbott, Boston Scientific, and Medtronic. Rahul Doshi is a consultant for Abbott. Dr Exner is a consultant for Abbott, Boston Scientific, GE Healthcare, and Medtronic and receives institutional research grants from Abbott Vascular. Dr Ip is a consultant for Abbott and Medtronic and has a study committee membership for Boston Scientific and Milestone Pharmaceuticals. Dr Rashtian is a consultant and speaker for Abbott, Johnson & Johnson, and Sanofi and receives an institutional research grant from Abbott. Dr Ganz is employed and has stocks from Abbott. C. Hubbard is employed and has stocks from Abbott. J. Nevo is employed and has stocks from Abbott. A. Bulusu is employed and has stocks from Abbott. Dr Reddy is a consultant for Abbott and unrelated to this article, has served as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Anumana, Apama Medical-Boston Scientific, APN Health, Append Medical, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, Cardiofocus, CardioNXT/AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EP Frontiers, Farapulse-Boston Scientific, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Laminar Medical, LuxMed, Medlumics, Neutrace, Nuvera-Biosense Webster, Oracle Health, Pulse Biosciences, Restore Medical, Sirona Medical, SoundCath; unrelated to this work, has served as a consultant for Adagio Medical, AtriAN, Biosense Webster, BioTel Heart, Biotronik, Boston Scientific, Cairdac, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Novo Nordisk, Philips; and has equity in Atraverse, DRS Vascular, Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. The other authors report no conflicts.

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