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BIO|CONCEPT.Amvia Study

Sponsor
Biotronik Australia Pty Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05610176
Collaborator
Biotronik SE & Co. KG (Industry)
50
Enrollment
1
Location
1
Arm
21.3
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Amvia Sky pacemaker or CRT-P device
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
BIO|CONCEPT.Amvia, First in Human Study for the Amvia/Solvia Pacemaker Family
Actual Study Start Date :
Nov 23, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Amvia Sky pacemaker or CRT-P implantation

Patients implanted with an Amvia Sky pacemaker or CRT-P device

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.

Outcome Measures

Primary Outcome Measures

  1. Serious adverse device effect (SADE)-free rate after 12 months [12 months]

    Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Alfred Hospital Melbourne Victoria Australia 3004

Sponsors and Collaborators

  • Biotronik Australia Pty Ltd.
  • Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Justin Mariani, Dr, The Alfred

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biotronik Australia Pty Ltd.
ClinicalTrials.gov Identifier:
NCT05610176
Other Study ID Numbers:
  • BA115
First Posted:
Nov 9, 2022
Last Update Posted:
Dec 19, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Biotronik Australia Pty Ltd.
Cardiac pacemaker
CRT-P
Additional relevant MeSH terms:
Bradycardia

Study Results

No Results Posted as of Dec 19, 2022