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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Acticor/Rivacor ICDs/CRT-Ds	Acticor/Rivacor ICDs/CRT-Ds	Implant of the new Cor Family internal cardioverter defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Acticor/Rivacor ICDs/CRT-Ds	Plexa S DX	Implant of the new Cor Family internal cardioverter defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting

Primary Outcome Measures

Name	Time	Method
Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up	3 months	Serious Adverse Device Effect (SADE)-free rate possibly or securely related to the Cor Family Internal Cardioverter Defibrillators (ICDs) / Cardiac Resynchronisation Therapy-Defibrillators (CRT-Ds) until 3-month follow-up

Secondary Outcome Measures

Name	Time	Method
Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate	3 months, 12 months	Application of the Kaplan-Meier method to estimate the 3-month (92 days) SADE-free rate and the 12-month (365 days) SADE-free rate
Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator	3 months	Investigators were asked to assess the overall handling of the Automatic LV VectorOpt test in patients who received a CRT-device. Assessments were collected during implantation, pre-hospital discharge, and 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate - poor -very poor.
Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator	3 months	Investigator were asked to assess the overall handling of the CRT AutoAdapt feature in patients who received a CRT-device. Assessments were collected during the 3-month follow-up visit. The following options could be chosen by the investigator: Very good - good - adequate -poor -very poor.

Locations (13): Charité Universitätsmedizin Berlin
🇩🇪
Berlin, Germany
Herz- und Diabeteszentrum NRW
🇩🇪
Bad Oeynhausen, Germany
National Hospital of Cardiology
🇭🇺
Balatonfüred, Hungary
Kepler Universitätsklinikum
🇦🇹
Linz, Austria
Pauls Stradins Clinical University Hospital
🇱🇻
Riga, Latvia
Inselspital - Universitätsspital Bern
🇨🇭
Bern, Switzerland
Universitätsspital Zürich
🇨🇭
Zürich, Switzerland
Hospital Medisch Spectrum Twente
🇳🇱
Enschede, Netherlands
Semmelweis Medical University
🇭🇺
Budapest, Hungary
SRH Wald-Klinikum Gera GmbH
🇩🇪
Gera, Germany
East-Slovak Cardiology Institute (VUSCH)
🇸🇰
Košice, Slovakia
SRH Zentralklinikum Suhl
🇩🇪
Suhl, Germany
Erasmus Medical Center
🇳🇱
Rotterdam, Netherlands