- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03891329
Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead
January 3, 2022 updated by: Biotronik SE & Co. KG
BIO|MASTER.Cor Family Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Linz, Austria
- Kepler Universitätsklinikum
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Bad Oeynhausen, Germany
- Herz- und Diabeteszentrum NRW
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Berlin, Germany
- Charité Universitätsmedizin Berlin
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Gera, Germany
- SRH Wald-Klinikum Gera GmbH
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Suhl, Germany
- SRH Zentralklinikum Suhl
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Balatonfüred, Hungary
- National Hospital of Cardiology
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Budapest, Hungary
- Semmelweis Medical University
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Riga, Latvia
- Pauls Stradins Clinical University Hospital
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Enschede, Netherlands
- Hospital Medisch Spectrum Twente
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Rotterdam, Netherlands
- Erasmus Medical Center
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Košice, Slovakia
- East-Slovak Cardiology Institute (VUSCH)
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Bern, Switzerland
- Inselspital - Universitätsspital Bern
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Zürich, Switzerland
- Universitätsspital Zürich
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 97 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: 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
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pre-defined device programming, measurements and follow-up schedule
Implantation, measurements and follow-up schedule
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cor Family-related SADE-free rate until 3-month follow-up
Time Frame: 3 months
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SADE-free rate related to the Cor Family ICDs/CRT-Ds
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kaplan-Meier estimate for the Cor Family related SADE-free rate
Time Frame: 3 months, 12 months
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Application of the Kaplan-Meier method to estimate the 3-month SADE-free rate and the 12-month SADE-free rate
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3 months, 12 months
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Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator
Time Frame: 3 months
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Investigator appraisal of the Overall handling of the Feature (score: Very good/good/ adequate/poor/very poor)
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3 months
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4. Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator
Time Frame: 3 months
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Investigator appraisal of the overall handling of the Feature (score: Very good/good/ adequate/poor/very poor)
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jan Steffel, MD, Universitätsspital Zürich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2019
Primary Completion (Actual)
December 21, 2020
Study Completion (Actual)
September 24, 2021
Study Registration Dates
First Submitted
February 11, 2019
First Submitted That Met QC Criteria
March 25, 2019
First Posted (Actual)
March 27, 2019
Study Record Updates
Last Update Posted (Actual)
January 4, 2022
Last Update Submitted That Met QC Criteria
January 3, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TA115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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