BIO|CONCEPT.Amvia Study

Launched by BIOTRONIK AUSTRALIA PTY LTD. · Nov 2, 2022

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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