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Completed

NCT Number: NCT05610176

BIO|CONCEPT.Amvia Study

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Hunter Hospital, New Lambton Heights, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Serious Adverse Device Effect (SADE)-Free Rate After 12 Months

    Time frame: 12 months

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

Other outcomes

  1. Right Atrial Sensing Amplitude

    Time frame: 12 months

    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.

  2. Right Atrial Pacing Threshold

    Time frame: 12 months

    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.

  3. Right Ventricular Sensing Amplitude

    Time frame: 12 months

    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.

  4. Right Ventricular Pacing Threshold

    Time frame: 12 months

    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.

  5. Left Ventricular Sensing Amplitude

    Time frame: 12 months

    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.

  6. Left Ventricular Pacing Threshold

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Biotronik Australia Pty Ltd.

Industry

Collaborators

  • Biotronik SE & Co. KG

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2022
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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