At a glance
ClinicalIndex Comparison Record- ✓Standard indication for pacemaker or CRT-P implantation (de novo, upgrade, or replacement)
- ✓Ability to understand the nature of the study and provide informed consent
- ✓Willingness and ability to complete all follow-up visits at the study site
- ✓Acceptance of CardioMessenger use and BIOTRONIK Home Monitoring concept
- ✕Planned conduction system pacing
- ✕Planned atrial anti-tachycardia pacing (aATP) without known history of atrial arrhythmia, or with permanent atrial fibrillation
- ✕Planned cardiac surgical procedures or interventional measures (other than the study procedure) within 12 months
- ✕Pregnancy or breast feeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BIO|CONCEPT.Amvia, First in Human Study for the Amvia/Solvia Pacemaker Family
In Brief
A clinical study evaluating Amvia Sky pacemaker or CRT-P device for Bradycardia and Heart Failure. Completed, enrolled 52 participants across 7 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.