Clinical trial NCT03891329: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Tachyarrhythmia
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2019-03-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Cor Family-related Serious Adverse Device Effect (SADE)-Free Rate Until 3-month Follow-up
timeFrame: 3 months
Secondary outcomes:
measure: Kaplan-Meier Estimate for the Cor Family Related SADE-free Rate
timeFrame: 3 months, 12 months
measure: Number of Handling-Assessments of the Automatic LV VectorOpt Test (CRT-devices Only) by the Investigator
timeFrame: 3 months
measure: Number of Handling-Assessments for the Overall Handling of the CRT AutoAdapt Feature (CRT-devices Only) by the Investigator
timeFrame: 3 months
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl
city: Balatonfüred
country: Hungary
facility: National Hospital of Cardiology
city: Budapest
country: Hungary
facility: Semmelweis Medical University
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Enschede
country: Netherlands
facility: Hospital Medisch Spectrum Twente
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Košice
country: Slovakia
facility: East-Slovak Cardiology Institute (VUSCH)
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspital Bern
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Universitätsspital Zürich
name: Jan Steffel, MD
role: PRINCIPAL_INVESTIGATOR
References: