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

Biotronik SE & Co. KG130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

130

Conditions

Heart Failure Tachyarrhythmia

Interventions

Acticor/Rivacor ICDs/CRT-DsDEVICE

pre-defined device programming, measurements and follow-up schedule

Plexa S DXDEVICE

Implantation, measurements and follow-up schedule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (13)

Kepler Universitätsklinikum

Linz, Austria

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Charité Universitätsmedizin Berlin

Berlin, Germany

Outcomes

Primary Outcomes

Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up

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

Time frame: 3 months

Secondary Outcomes

Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate

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

Time frame: 3 months, 12 months

Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator

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.

Time frame: 3 months

Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator

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.

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.