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

NCT03891329 | Completed Results

• 1 other identifier: TA115
• Study Type: interventional
• Target: 130
• Locations: 7 countries
• Sites: 13

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.

Conditions

Heart Failure; Tachyarrhythmia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  3 months, 12 months

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

  3 months

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

  3 months

Study Arms (1)

Acticor/Rivacor ICDs/CRT-Ds

OTHER

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; Device: Plexa S DX

Interventions

Acticor/Rivacor ICDs/CRT-Ds DEVICE

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

Acticor/Rivacor ICDs/CRT-Ds

Plexa S DX DEVICE

Implantation, measurements and follow-up schedule

Acticor/Rivacor ICDs/CRT-Ds

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (13)

Kepler Universitätsklinikum

Linz, Austria

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, Germany

Location

SRH Wald-Klinikum Gera GmbH

Gera, Germany

Location

SRH Zentralklinikum Suhl

Suhl, Germany

Location

National Hospital of Cardiology

Balatonfüred, Hungary

Location

Semmelweis Medical University

Budapest, Hungary

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Hospital Medisch Spectrum Twente

Enschede, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

East-Slovak Cardiology Institute (VUSCH)

Košice, Slovakia

Location

Inselspital - Universitätsspital Bern

Bern, Switzerland

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Heart Failure; Tachycardia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director Clinical Project Management
• Organization: BIOTRONIK SE & Co.KG

mathias.freudigmann@biotronik.com

+49 30 68905

Study Officials

• Jan Steffel, MD

  Universitätsspital Zürich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: March 27, 2019
• Study Start: April 30, 2019
• Primary Completion: December 21, 2020
• Study Completion: September 24, 2021
• Last Updated: September 27, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); LA (1); HU (2); DE (4); AU (1); NL (2); SL (1)