BIO|CONCEPT.Amvia Study

Study Overview
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Brief Summary
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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.

Official Title
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BIO|CONCEPT.Amvia, First in Human Study for the Amvia/Solvia Pacemaker Family

Conditions
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Bradycardia, Heart Failure

Intervention / Treatment
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* Device: Amvia Sky pacemaker or CRT-P device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amvia Sky pacemaker or CRT-P implantation<br>Patients implanted with an Amvia Sky pacemaker or CRT-P device | Device: Amvia Sky pacemaker or CRT-P device<br>* Subjects with an indication for a pacemaker or CRT-P device will be implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. Device programming will be done according to the medical needs of the subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse device effect (SADE)-free rate after 12 months | Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac pacemaker, CRT-P