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Completed

NCT Number: NCT03891329

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

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.

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachyarrhythmia Tachycardia

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kepler Universitätsklinikum, Linz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acticor/Rivacor ICDs/CRT-Ds

Device

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

Plexa S DX

Device

Implantation, measurements and follow-up schedule

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

BIO|MASTER.Cor Family Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 27, 2019
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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