Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead

Last updated: May 30, 2024
Sponsor: Biotronik SE & Co. KG
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Heart Failure

Hyponatremia

Treatment

Acticor/Rivacor ICDs/CRT-Ds

Plexa S DX

Clinical Study ID

NCT03891329
TA115
  • Ages 18-99
  • All Genders

Study Summary

Post-Market Clinical Follow-up of the new Cor Family ICDs/CRT-Ds (Acticor, Rivacor) and the new Plexa ProMRI S DX right ventricular lead to provide post-market data and supporting evidence for the clinical safety and performance of the devices.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Standard indication for ICD or CRT-D therapy according to clinical guidelines

  • Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existingICD/CRT-D or pacemaker implant

  • Able to understand the nature of study and to provide written informed consent

  • Willing and able to perform all follow-up visits at the study site

  • Willing and able to use the CardioMessenger and accepts the BIOTRONIK HomeMonitoring concept

Exclusion

Exclusion Criteria:

  • Contraindication to ICD and CRT-D therapy

  • Planned for implantation of a CRT-DX system

  • For VR-T DX devices: permanent atrial tachyarrhythmia

  • For VR-T DX devices: patients requiring atrial pacing

  • Less than 18 years old

  • Pregnant or breast feeding

  • Participating in another interventional clinical investigation

  • Life-expectancy is less than 12 months

  • Cardiac surgical procedure planned within 12 months after implantation (includinginterventional procedures like ablation, valve replacement, heart transplant etc.).Procedures to occur during or prior to implantation are not exclusionary

Study Design

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: Acticor/Rivacor ICDs/CRT-Ds
Phase:
Study Start date:
April 30, 2019
Estimated Completion Date:
September 24, 2021

Connect with a study center

  • Kepler Universitätsklinikum

    Linz,
    Austria

    Site Not Available

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen,
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

  • Klinikum Coburg

    Coburg,
    Germany

    Site Not Available

  • SRH Wald-Klinikum Gera GmbH

    Gera,
    Germany

    Site Not Available

  • SRH Zentralklinikum Suhl

    Suhl,
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg,
    Germany

    Site Not Available

  • National Hospital of Cardiology

    Balatonfüred,
    Hungary

    Site Not Available

  • Semmelweis Medical University

    Budapest,
    Hungary

    Site Not Available

  • Pauls Stradins Clinical University Hospital

    Riga,
    Latvia

    Site Not Available

  • Hospital Medisch Spectrum Twente

    Enschede,
    Netherlands

    Site Not Available

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Site Not Available

  • East-Slovak Cardiology Institute (VUSCH)

    Košice,
    Slovakia

    Site Not Available

  • Inselspital - Universitätsspital Bern

    Bern,
    Switzerland

    Site Not Available

  • Universitätsspital Zürich

    Zürich,
    Switzerland

    Site Not Available

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