Heart FailureNCT03891329
Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead
A study testing Acticor/Rivacor ICDs/CRT-Ds and Plexa S DX in people with Heart Failure and Tachyarrhythmia, run by Biotronik SE & Co. KG at 13 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure, Tachyarrhythmia
- What is being tested?
- Acticor/Rivacor ICDs/CRT-Ds and Plexa S DX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 30 Apr 2019to 24 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
Germany4 sites
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
Charité Universitätsmedizin Berlin
Berlin
SRH Wald-Klinikum Gera GmbH
Gera
SRH Zentralklinikum Suhl
Suhl
Hungary2 sites
National Hospital of Cardiology
Balatonfüred
Semmelweis Medical University
Budapest
Netherlands2 sites
Hospital Medisch Spectrum Twente
Enschede
Erasmus Medical Center
Rotterdam
Switzerland2 sites
Inselspital - Universitätsspital Bern
Bern
Universitätsspital Zürich
Zurich
About this study
Official title: 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.
- Conditions
- Heart Failure, Tachyarrhythmia
- Being tested
- Acticor/Rivacor ICDs/CRT-Ds, Plexa S DX
- Medical subject headings
- Heart Failure, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acticor/Rivacor ICDs/CRT-DsDevice
pre-defined device programming, measurements and follow-up schedule
Plexa S DXDevice
Implantation, measurements and follow-up schedule
| Study group | Role | What they receive |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | Other | Implant of the new Cor Family internal cardioverter defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting Receives: Device: Acticor/Rivacor ICDs/CRT-Ds; Device: Plexa S DX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up
Serious Adverse Device Effect (SADE)-free rate possibly or securely related to the Cor Family Internal Cardioverter Defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) until 3-month follow-up
Measured: 3 months
Secondary outcomes (3)
Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate
Application of the Kaplan-Meier method to estimate the 3-month (92 days) SADE-free rate and the 12-month (365 days) SADE-free rate
Measured: 3 months, 12 months
Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator
Investigators were asked to assess the overall handling of the Automatic LV VectorOpt test in patients who received a CRT-device. Assessments were collected during implantation, pre-hospital discharge, and 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate - poor -very poor.
Measured: 3 months
Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator
Investigator were asked to assess the overall handling of the CRT AutoAdapt feature in patients who received a CRT-device. Assessments were collected during the 3-month follow-up visit.
The following options could be chosen by the investigator: Very good - good - adequate -poor -very poor.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start30 Apr 2019
- Primary completion21 Dec 2020
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Steffel, MD, Principal investigator, Universitätsspital Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891329
- Sponsor's protocol ID
- TA115
- Status last verified
- May 2024
- First submitted
- 11 Feb 2019
- Last updated
- 27 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO|MASTER.Cor Family Study
- ClinicalTrials.gov ID
- NCT03891329
- Acronym / sponsor ID
- TA115
- Conditions
- Heart Failure, Tachyarrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Posted 27 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Ds | Other | Device: Acticor/Rivacor ICDs/CRT-Ds, Device: Plexa S DXImplant of the new Cor Family internal cardioverter defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acticor/Rivacor ICDs/CRT-Dspre-defined device programming, measurements and follow-up schedule | Device | Acticor/Rivacor ICDs/CRT-Ds |
| Plexa S DXImplantation, measurements and follow-up schedule | Device | Acticor/Rivacor ICDs/CRT-Ds |
Primary outcome
Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up
Time frame: 3 months
Serious Adverse Device Effect (SADE)-free rate possibly or securely related to the Cor Family Internal Cardioverter Defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) until 3-month follow-up
3 secondary outcomes
Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate
Time frame: 3 months, 12 months
Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator
Time frame: 3 months
Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Steffel, MD principal investigator
Universitätsspital Zürich
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acticor/Rivacor ICDs/CRT-Ds and Plexa S DX in people with Heart Failure and Tachyarrhythmia, run by Biotronik SE & Co. KG at 13 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Hungary, Netherlands, Switzerland, Austria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.