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Completed

NCT Number: NCT06018818

Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family

The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study.

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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–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kepler Universitätsklinikum, Linz, Austria

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 de novo, upgrade or replacement pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation
  • 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 cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
  • Known pregnancy or breast feeding
  • Age less than 18 years
  • Participation in another interventional clinical investigation
  • Life-expectancy less than 12 months

Treatment and study plan

Amvia/Solvia pacemaker family

Device

Implantation of a pacemaker or CRT-P devices

Primary outcomes

  1. SADE-free rate at 6 months

    Time frame: 6 months

    Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months

Secondary outcomes

  1. SADE-free rate at 12 months

    Time frame: 12 months

    Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months

  2. CRT AutoAdapt performance

    Time frame: 12 months

    CRT AutoAdapt: different pacing percentages

  3. CRT AutoAdapt AV delay

    Time frame: 12 months

    Mean adapted AV delay after pace/sense

  4. Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator

    Time frame: 12 months

    Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)

  5. Auto LV VectorOpt

    Time frame: 12 months

    Time needed for threshold measurement

  6. Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator

    Time frame: 2 months

    Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)

  7. aATP-related ADEs and SADEs

    Time frame: 12 months

    aATP-related ADEs and SADEs

  8. Sensing performance of device-based measurements

    Time frame: 12 months

    The appropriateness of sensing performance will be assessed by calculating the percentage of appropriate sensing for all leads.

  9. Pacing performance of device-based measurements

    Time frame: 12 months

    The appropriateness of pacing performance will be assessed by calculating the percentage of appropriate pacing for all leads.

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 31, 2023
Registry last updated
Aug 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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