N/A N=52 Treatment

BIO|CONCEPT.Amvia Study

Bradycardia · Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT05610176 ↗

Enrolled (actual)

Serious AEs

57.7%

Results posted

Jul 2025

Primary outcome: Primary: Serious Adverse Device Effect (SADE)-Free Rate After 12 Months — 52 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Amvia Sky pacemaker or CRT-P device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Biotronik Australia Pty Ltd.
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Serious Adverse Device Effect (SADE)-Free Rate After 12 Months	52	—

Summary

The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation. The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the pacemakers will be done according to the participant´s therapeutical needs.

Eligibility Criteria

Inclusion Criteria

Standard indication for pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation, including de novo, upgrade or replacement implantations
Ability to understand the nature of the study
Willingness to provide written informed consent
Ability and willingness to perform all follow-up visits at the study site
Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept

Exclusion Criteria

Planned for conduction system pacing
Planned for activation of atrial anti-tachycardia pacing (aATP) without known history of atrial arrhythmia, or with permanent atrial fibrillation (AF)
Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
Pregnant or breast feeding
Age less than 18 years
Participation in another interventional clinical investigation according to the definition given in the study protocol
Life-expectancy less than 12 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05610176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.