BIO|CONCEPT.Amvia Study

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Serious Adverse Device Effect (SADE)-Free Rate After 12 Months	12 months	Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate

Secondary Outcome Measures

Name	Time	Method

Locations (7): John Hunter Hospital
🇦🇺
New Lambton Heights, New South Wales, Australia
Advara Heart Care Wesley
🇦🇺
Auchenflower, Queensland, Australia
Gold Coast University Hospital
🇦🇺
Southport, Queensland, Australia
Royal Hobart Hospital
🇦🇺
Hobart, Tasmania, Australia
Peninsula Heart Centre
🇦🇺
Frankston, Victoria, Australia
Christchurch Hospital
🇳🇿
Christchurch, New Zealand
The Alfred Hospital
🇦🇺
Melbourne, Victoria, Australia
John Hunter Hospital
🇦🇺New Lambton Heights, New South Wales, Australia