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

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.

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