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

Biotronik

Status: Completed

Conditions: Heart Failure; Tachyarrhythmia

Treatments: Device: Plexa S DX; Device: Acticor/Rivacor ICDs/CRT-Ds

Study type: Interventional

Funder types: Industry

Identifiers

NCT03891329

TA115

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Acticor/Rivacor ICDs/CRT-Ds

Other group

Description:

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

Treatment:

Device: Plexa S DX

Device: Acticor/Rivacor ICDs/CRT-Ds