CompletedNot Applicable

BIO|CONCEPT.Amvia Study

Australia52 participantsStarted 2022-11-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Serious Adverse Device Effect (SADE)-Free Rate After 12 Months

Timeframe: 12 months

Trial details

NCT IDNCT05610176

SponsorBiotronik Australia Pty Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-11

Results submitted2025-04-28