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

Primary Purpose

Heart Failure, Tachyarrhythmia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Acticor/Rivacor ICDs/CRT-Ds
Plexa S DX
Sponsored by
Biotronik SE & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kepler Universitätsklinikum
  • Herz- und Diabeteszentrum NRW
  • Charité Universitätsmedizin Berlin
  • SRH Wald-Klinikum Gera GmbH
  • SRH Zentralklinikum Suhl
  • National Hospital of Cardiology
  • Semmelweis Medical University
  • Pauls Stradins Clinical University Hospital
  • Hospital Medisch Spectrum Twente
  • Erasmus Medical Center
  • East-Slovak Cardiology Institute (VUSCH)
  • Inselspital - Universitätsspital Bern
  • Universitätsspital Zürich

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Acticor/Rivacor ICDs/CRT-Ds

Arm Description

Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting

Outcomes

Primary Outcome Measures

Cor Family-related SADE-free rate until 3-month follow-up
SADE-free rate related to the Cor Family ICDs/CRT-Ds

Secondary Outcome Measures

Kaplan-Meier estimate for the Cor Family related SADE-free rate
Application of the Kaplan-Meier method to estimate the 3-month SADE-free rate and the 12-month SADE-free rate
Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator
Investigator appraisal of the Overall handling of the Feature (score: Very good/good/ adequate/poor/very poor)
4. Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator
Investigator appraisal of the overall handling of the Feature (score: Very good/good/ adequate/poor/very poor)

Full Information

First Posted
February 11, 2019
Last Updated
January 3, 2022
Sponsor
Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT03891329
Brief Title
Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead
Official Title
BIO|MASTER.Cor Family Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
December 21, 2020 (Actual)
Study Completion Date
September 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Tachyarrhythmia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acticor/Rivacor ICDs/CRT-Ds
Arm Type
Other
Arm Description
Implant of the new Cor Family ICDs and Plexa ProMRI S DX lead (if applicable). Device measurements, pre-defined programming and Adverse Event Reporting
Intervention Type
Device
Intervention Name(s)
Acticor/Rivacor ICDs/CRT-Ds
Intervention Description
pre-defined device programming, measurements and follow-up schedule
Intervention Type
Device
Intervention Name(s)
Plexa S DX
Intervention Description
Implantation, measurements and follow-up schedule
Primary Outcome Measure Information:
Title
Cor Family-related SADE-free rate until 3-month follow-up
Description
SADE-free rate related to the Cor Family ICDs/CRT-Ds
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Kaplan-Meier estimate for the Cor Family related SADE-free rate
Description
Application of the Kaplan-Meier method to estimate the 3-month SADE-free rate and the 12-month SADE-free rate
Time Frame
3 months, 12 months
Title
Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator
Description
Investigator appraisal of the Overall handling of the Feature (score: Very good/good/ adequate/poor/very poor)
Time Frame
3 months
Title
4. Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator
Description
Investigator appraisal of the overall handling of the Feature (score: Very good/good/ adequate/poor/very poor)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Steffel, MD
Organizational Affiliation
Universitätsspital Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kepler Universitätsklinikum
City
Linz
Country
Austria
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
SRH Wald-Klinikum Gera GmbH
City
Gera
Country
Germany
Facility Name
SRH Zentralklinikum Suhl
City
Suhl
Country
Germany
Facility Name
National Hospital of Cardiology
City
Balatonfüred
Country
Hungary
Facility Name
Semmelweis Medical University
City
Budapest
Country
Hungary
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
Country
Latvia
Facility Name
Hospital Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
East-Slovak Cardiology Institute (VUSCH)
City
Košice
Country
Slovakia
Facility Name
Inselspital - Universitätsspital Bern
City
Bern
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zürich
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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