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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891329
Recruitment Status : Active, not recruiting
First Posted : March 27, 2019
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Tachyarrhythmia Device: Acticor/Rivacor ICDs/CRT-Ds Device: Plexa S DX Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: BIO|MASTER.Cor Family Study
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : September 30, 2021

Arm Intervention/treatment
Acticor/Rivacor ICDs/CRT-Ds
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Device: Acticor/Rivacor ICDs/CRT-Ds
pre-defined device programming, measurements and follow-up schedule

Device: Plexa S DX
Implantation, measurements and follow-up schedule




Primary Outcome Measures :
  1. Cor Family-related SADE-free rate until 3-month follow-up [ Time Frame: 3 months ]
    SADE-free rate related to the Cor Family ICDs/CRT-Ds


Secondary Outcome Measures :
  1. Kaplan-Meier estimate for the Cor Family related SADE-free rate [ Time Frame: 3 months, 12 months ]
    Application of the Kaplan-Meier method to estimate the 3-month SADE-free rate and the 12-month SADE-free rate

  2. Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator [ Time Frame: 3 months ]
    Investigator appraisal of the Overall handling of the Feature (score: Very good/good/ adequate/poor/very poor)

  3. 4. Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator [ Time Frame: 3 months ]
    Investigator appraisal of the overall handling of the Feature (score: Very good/good/ adequate/poor/very poor)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 existing ICD/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 Home Monitoring concept

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 (including interventional procedures like ablation, valve replacement, heart transplant etc.). Procedures to occur during or prior to implantation are not exclusionary

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891329


Locations
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Austria
Kepler Universitätsklinikum
Linz, Austria
Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Charité Universitätsmedizin Berlin
Berlin, Germany
SRH Wald-Klinikum Gera GmbH
Gera, Germany
SRH Zentralklinikum Suhl
Suhl, Germany
Hungary
National Hospital of Cardiology
Balatonfüred, Hungary
Semmelweis Medical University
Budapest, Hungary
Latvia
Pauls Stradins Clinical University Hospital
Riga, Latvia
Netherlands
Hospital Medisch Spectrum Twente
Enschede, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Slovakia
East-Slovak Cardiology Institute (VUSCH)
Košice, Slovakia
Switzerland
Inselspital - Universitätsspital Bern
Bern, Switzerland
Universitätsspital Zürich
Zürich, Switzerland
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
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Principal Investigator: Jan Steffel, MD Universitätsspital Zürich
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Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT03891329    
Other Study ID Numbers: TA115
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes