BIO|MASTER.Ilivia Family / Plexa

Not Applicable

Completed

Brief Summary: 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ilivia ICD and Plexa lead	Plexa ICD lead	Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting
Ilivia ICD Family	Ilivia ICD Family	Implant of the new Ilivia ICD Family. Device measurements, pre-defined programming and Adverse Event Reporting
Plexa ICD lead	Plexa ICD lead	Implant of the new Plexa ICD lead. Device measurements and Adverse Event Reporting
Ilivia ICD and Plexa lead	Ilivia ICD Family	Implant of the new Ilivia ICD Family and the new Plexa lead. Device measurements, pre-defined programming and Adverse Event Reporting

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up	3 months	The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate
Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up	3 months	The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate
Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up	6 months	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

Locations (25): Liverpool Hospital
🇦🇺
Liverpool, Australia
Nambour General Hospital
🇦🇺
Nambour, Australia
Universitätsklinikum St. Pölten
🇦🇹
St. Pölten, Austria
CHU Brest
🇫🇷
Brest, France
HDZ NRW Bad Oeynhausen
🇩🇪
Bad Oeynhausen, Germany
Universitätsklinikum Essen
🇩🇪
Essen, Germany
Universitätsklinikum Erlangen
🇩🇪
Erlangen, Germany
SRH Wald-Klinikum Gera GmbH
🇩🇪
Gera, Germany
Westpfalz-Klinikum Kaiserslautern
🇩🇪
Kaiserslautern, Germany
Universitätsklinikum Würzburg
🇩🇪
Würzburg, Germany
Tel Aviv Sourasky Medical Center
🇮🇱
Tel Aviv, Israel
Chaim Sheba Medical Center
🇮🇱
Ramat Gan, Israel
Hospital de Bellvitge
🇪🇸
Barcelona, Spain
Hospital de Donostia
🇪🇸
San Sebastian, Spain
Hospital Universitario Virgen de Macarena
🇪🇸
Sevilla, Spain
Universitätsspital Basel
🇨🇭
Basel, Switzerland
Kantonspital Luzern
🇨🇭
Luzern, Switzerland
Odense University Hospital
🇩🇰
Odense, Denmark
Hegau-Bodensee-Klinikum Singen
🇩🇪
Singen, Germany
Pauls Stradins Clinical University Hospital
🇱🇻
Riga, Latvia
Hufeland Klinikum GmbH
🇩🇪
Bad Langensalza, Germany
Städtisches Klinikum Brandenburg GmbH
🇩🇪
Brandenburg, Germany
Universitätsklinikum Freiburg
🇩🇪
Freiburg, Germany
National Heart Center Singapore
🇸🇬
Singapore, Singapore
Inselspital Bern
🇨🇭
Bern, Switzerland