BIO|CONCEPT.Amvia Study

Sponsor
Biotronik Australia Pty Ltd.
Study ID
NCT05610176
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amvia Sky pacemaker or CRT-P device — 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.

Study Details

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.

Key Dates

Start date
Nov 23, 2022
Status verified
Jun 2024
Primary completion
Jun 11, 2024
Completion
Jun 11, 2024

Study Design

Enrollment
52 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Amvia Sky pacemaker or CRT-P implantation
    Patients implanted with an Amvia Sky pacemaker or CRT-P device

Primary Outcome Measure

Serious Adverse Device Effect (SADE)-Free Rate After 12 Months [ Time Frame: 12 months ]

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