NCT05610176

BIO|CONCEPT.Amvia Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Biotronik Australia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bradycardia
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Amvia Sky pacemaker or CRT-P device	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.

Timeline

• Start date: 2022-11-23
• Primary completion: 2024-06-11
• Completion: 2024-06-11
• First posted: 2022-11-09
• Last updated: 2025-07-24
• Results posted: 2025-07-24

Locations

7 sites across 2 countries: Australia, New Zealand