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

Heart Failure Clinical Trial

Official title:

BIO|MASTER.Cor Family Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891329
• Other study ID #: TA115
• Status: Completed
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: September 24, 2021

Study information

• Verified date: January 2022
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: September 24, 2021
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Tachyarrhythmia
• Tachycardia

Intervention

Device:
• Acticor/Rivacor ICDs/CRT-Ds
pre-defined device programming, measurements and follow-up schedule
• Plexa S DX
Implantation, measurements and follow-up schedule

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Austria,  Germany,  Hungary,  Latvia,  Netherlands,  Slovakia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cor Family-related SADE-free rate until 3-month follow-up	SADE-free rate related to the Cor Family ICDs/CRT-Ds	3 months
Secondary	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	3 months, 12 months
Secondary	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)	3 months
Secondary	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)	3 months