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BIO|CONCEPT.Amvia Study

NCT05610176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-07-24

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    collaborator INDUSTRY

  • Biotronik Australia Pty Ltd.

    lead INDUSTRY

Principal Investigators

  • Justin Mariani, Dr · The Alfred

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-23
Primary Completion
2024-06-11
Completion
2024-06-11

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05610176 on ClinicalTrials.gov