BIO|MASTER.Ilivia Family / Plexa

BIO|MASTER.Ilivia Family / Plexa

Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region

Inclusion Criteria:

• Standard indication for ICD or CRT-D therapy according to clinical practice
• De novo implantation or upgrade/exchange (group A only) from existing ICD, CRT-D or pacemaker implant
• Patient is able to understand the nature of the clinical investigation and provides written informed consent
• Patient is able and willing to complete all routine study visits at the investigational site
• Patient accepts Home Monitoring concept
• Age ≥ 18 years

Exclusion Criteria:

• Contraindication to ICD or CRT-D therapy, respectively
• For CRT-D patients in group A only: physician not willing to activate MultiPole Pacing in the patient
• Cardiac surgical procedure planned within 6 months after implantation (including also interventional procedures like ablation, valve replacement etc.). Procedures to occur during or prior to implantation are not exclusionary.
• Expected to receive heart transplant or ventricular assist device within 6 months
• Life expectancy less than 6 months
• Participation in any other interventional clinical investigation
• Pregnant or breastfeeding at time of enrollment