BIO|MASTER.Ilivia Family / Plexa

Study Overview
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Brief Summary
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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

Official Title
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BIO|MASTER.Ilivia Family / Plexa

Conditions
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Heart Failure, Tachyarrhythmia

Intervention / Treatment
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* Device: Ilivia ICD Family
* Device: Plexa ICD lead


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 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

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ilivia ICD Family<br>Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting | Device: Ilivia ICD Family<br>* pre-defined device programming, measurements and follow-up schedule<br>|
| Other: Plexa ICD lead<br>Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting | Device: Plexa ICD lead<br>* predefined follow-up schedule<br>|
| Other: Ilivia ICD and Plexa lead<br>Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting | Device: Ilivia ICD Family<br>* pre-defined device programming, measurements and follow-up schedule<br>Device: Plexa ICD lead<br>* predefined follow-up schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ilivia Family Related SADE-free Rate Through 3 Months | This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device | 3 months | 
| Plexa Related SADE-free Rate Through 6 Months | This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the Plexa lead | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up | Of all patients with spontaneous ventricular arrhythmia detected in the VF zone, and treated by ATP-one-shot, the percentage of patients with at least one successful termination will be determined | 6 months | 
| Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up | The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate | 3 months | 
| Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up | The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate | 3 months |