BIO|CONCEPT.Amvia Study

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Bradycardia
• Intervention / Treatment: Device: Amvia Sky pacemaker or CRT-P device

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, 2305
      • John Hunter Hospital
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Advara Heart Care Wesley
    • Southport, Queensland, Australia, 4215
      • Gold Coast University Hospital
  • Tasmania
    • Hobart, Tasmania, Australia, 7001
      • Royal Hobart Hospital
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Peninsula Heart Centre
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
• New Zealand
  • Christchurch, New Zealand, 8140
    • Christchurch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Device Effect (SADE)-Free Rate After 12 Months	Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right Atrial Sensing Amplitude	The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed in the right atrium.	12 months
Right Atrial Pacing Threshold	The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed in the right atrium.	12 months
Right Ventricular Sensing Amplitude	The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed in the right ventricle.	12 months
Right Ventricular Pacing Threshold	The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed in the right ventricle.	12 months
Left Ventricular Sensing Amplitude	The sensing amplitude is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum voltage of the heart's intrinsic electrical signals that a pacemaker can detect through its leads to monitor the heart's natural activity and decide whether pacing is needed. In this case refering to the lead placed next to the left ventricle.	12 months
Left Ventricular Pacing Threshold	The pacing threshold is measured using a programmer device during the follow-up examination of a pacemaker patient. It refers to the minimum amount of electrical energy required to consistently depolarize the myocardium, thereby triggering a cardiac contraction. In this case refering to the lead placed next to the left ventricle.	12 months

Collaborators and Investigators

• Sponsor: Biotronik Australia Pty Ltd.
• Collaborators: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Justin Mariani, Dr, The Alfred

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Actual): June 11, 2024
• Study Completion (Actual): June 11, 2024

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac pacemaker; CRT-P
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: BA115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No