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

BIO|MASTER.Cor Family Study

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 Overview

• Status: Completed
• Conditions: Heart Failure; Tachyarrhythmia
• Intervention / Treatment: Device: Acticor/Rivacor ICDs/CRT-Ds; Device: Plexa S DX

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria
    • Kepler Universitätsklinikum
• Germany
  • Bad Oeynhausen, Germany
    • Herz- und Diabeteszentrum NRW
  • Berlin, Germany
    • Charité Universitätsmedizin Berlin
  • Gera, Germany
    • SRH Wald-Klinikum Gera GmbH
  • Suhl, Germany
    • SRH Zentralklinikum Suhl
• Hungary
  • Balatonfüred, Hungary
    • National Hospital of Cardiology
  • Budapest, Hungary
    • Semmelweis Medical University
• Latvia
  • Riga, Latvia
    • Pauls Stradins Clinical University Hospital
• Netherlands
  • Enschede, Netherlands
    • Hospital Medisch Spectrum Twente
  • Rotterdam, Netherlands
    • Erasmus Medical Center
• Slovakia
  • Košice, Slovakia
    • East-Slovak Cardiology Institute (VUSCH)
• Switzerland
  • Bern, Switzerland
    • Inselspital - Universitätsspital Bern
  • Zürich, Switzerland
    • Universitatsspital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: Acticor/Rivacor ICDs/CRT-Ds; pre-defined device programming, measurements and follow-up schedule; Device: Plexa S DX; Implantation, measurements and follow-up schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	3 months

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Jan Steffel, MD, Universitatsspital Zurich

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Actual): December 21, 2020
• Study Completion (Actual): September 24, 2021

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia
• Other Study ID Numbers: TA115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No