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

Last updated: June 25, 2024
Sponsor: Biotronik SE & Co. KG
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Dysrhythmia

Low Blood Pressure (Hypotension)

Congestive Heart Failure

Treatment

Amvia/Solvia pacemaker family

Clinical Study ID

NCT06018818
BA114
  • Ages 18-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Standard indication for de novo, upgrade or replacement pacemaker or cardiacresynchronization 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 BIOTRONIKHome Monitoring® concept

Exclusion

Exclusion Criteria:

  • Planned for conduction system pacing

  • Planned cardiac surgical procedures or interventional measures other than the studyprocedure 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

Study Design

Total Participants: 125
Treatment Group(s): 1
Primary Treatment: Amvia/Solvia pacemaker family
Phase:
Study Start date:
August 23, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Kepler Universitätsklinikum

    Linz,
    Austria

    Site Not Available

  • Elisabeth-Krankenhaus Essen

    Essen,
    Germany

    Site Not Available

  • Kliniken Maria Hilf GmbH

    Mönchengladbach,
    Germany

    Site Not Available

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