BIO|CONCEPT.Amvia Study
Bradycardia, Heart Failure
About this trial
This is an interventional treatment trial for Bradycardia focused on measuring Cardiac pacemaker, CRT-P
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
Sites / Locations
- The Alfred Hospital
Arms of the Study
Arm 1
Experimental
Amvia Sky pacemaker or CRT-P implantation
Patients implanted with an Amvia Sky pacemaker or CRT-P device