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Clinical Trial
. 2025 Jun;22(6):1533-1540.
doi: 10.1016/j.hrthm.2024.11.032. Epub 2024 Nov 22.

Temperature-based rate response in a leadless pacemaker system

Mayer Y Rashtian  1 , James E Ip  2 , Derek V Exner  3 , Vivek Y Reddy  4 , Rahul N Doshi  5 , Pascal Defaye  6 , Robert C Canby  7 , Maria Grazia Bongiorni  8 , Morio Shoda  9 , Gerhard Hindricks  10 , Jordan R Nevo  11 , David Ligon  12 , Anu Bulusu  13 , Reinoud E Knops  14
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Free article
Clinical Trial

Temperature-based rate response in a leadless pacemaker system

Mayer Y Rashtian et al. Heart Rhythm. 2025 Jun.
Free article

Abstract

Background: A new dual-chamber leadless pacemaker (DR-LP) system, composed of 2 implantable devices in the right ventricle and right atrium, uses a less common temperature-based rate-response sensor. There is a need to understand the effectiveness of the rate response during exercise in both the ventricular (VR-LP) and atrial (AR-LP) devices.

Objective: We sought to determine whether temperature-based rate-responsive pacing is proportional to metabolic workload during an exercise test in a leadless pacemaker system.

Methods: After 6 weeks of implantation, we administered a treadmill exercise protocol to eligible participants concurrently enrolled in the LEADLESS II-Phase 2 and Aveir DR i2i studies. Programmed settings were optimized after a prior 6-minute walk test. We evaluated the ventricular and atrial rate-response sensors in participants implanted with the VR-LP and DR-LP system, respectively. For each device, the normalized slopes of sensor-indicated rate vs metabolic workload were aggregated across all analyzable patients. If the mean slope's 95% confidence interval (CI) fell within the prespecified 0.65 and 1.35 acceptance range, the rate response was considered proportional to metabolic demand.

Results: Seventeen participants had a mean ventricular rate-response slope of 0.93 ± 0.29 (CI, 0.78-1.08), which fell within the acceptance criteria (P = .001). Twenty participants had a mean atrial rate-response slope of 0.91 ± 0.28 (CI, 0.78-1.05), also falling within the prespecified criteria (P < .001).

Conclusion: The temperature-based sensor in a dual-chamber leadless pacemaker system was shown to be effective at modulating pacing rate in response to increased metabolic demand for right ventricular and atrial devices.

Gov identifier: NCT04559945 (LEADLESS II-Phase 2 study) and NCT05252702 (Aveir DR i2i study).

Keywords: Aveir; CAEP; Dual chamber; Leadless pacemaker; Rate response.

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Conflict of interest statement

Disclosures R.D., D.V.E., V.Y.R., R.E.K., J.E.I., and M.Y.R. report consulting fees from Abbott. P.D., D.V.E., R.E.K., and M.Y.R. report research grants from Abbott. D.V.E. reports honoraria from Abbott. J.E.I., D.V.E., V.Y.R., R.D., P.D., R.C., M.G.B., M.S., G.H., and R.E.K. serve as clinical study steering committee members. J.R.N., A.B. and D.L. are stock owners of Abbott. Disclosures unrelated to this manuscript are provided in the Supplement.

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