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

Study Overview
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Brief Summary
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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.

Official Title
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BIO|MASTER.Cor Family Study

Conditions
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Heart Failure, Tachyarrhythmia

Intervention / Treatment
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* Device: Acticor/Rivacor ICDs/CRT-Ds
* Device: Plexa S DX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Acticor/Rivacor ICDs/CRT-Ds<br>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<br>* pre-defined device programming, measurements and follow-up schedule<br>Device: Plexa S DX<br>* Implantation, measurements and follow-up schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cor Family-related SADE-free rate until 3-month follow-up | SADE-free rate related to the Cor Family ICDs/CRT-Ds | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kaplan-Meier estimate for the Cor Family related SADE-free rate | Application of the Kaplan-Meier method to estimate the 3-month SADE-free rate and the 12-month SADE-free rate | 3 months, 12 months | 
| Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator | Investigator appraisal of the Overall handling of the Feature (score: Very good/good/ adequate/poor/very poor) | 3 months | 
| 4. Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator | Investigator appraisal of the overall handling of the Feature (score: Very good/good/ adequate/poor/very poor) | 3 months |