BIO|MASTER.Ilivia Family / Plexa
Research type
Research Study
Full title
BIO|MASTER.Ilivia Family / Plexa
IRAS ID
207192
Contact name
Silke Kruger
Contact email
Sponsor organisation
Biotronik SE & Co. KG
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
This multi-centre, non-randomised study looks at two product ranges: the Ilivia ICD Family and the Plexa ICD Lead range. It aims to identify and evaluate residual risks that might still remain after risk analysis and mitigation, successful conformity assessment and CE-marking of these products. \nFurthermore, the study aims to provide additional data required by regulatory authorities outside the CE-region.\nThe two product ranges (i.e. the Ilivia ICD Family and the Plexa ICD Leads) may be used together in one patient as two elements of an implanted ICD system. They are both being investigated under a single study protocol.\nTwo categories of patients will be recruited: those at risk of sudden cardiac death from ventricular arrhythmias and those at risk of congestive heart failure.\nApproximately 30 hospitals globally will participate, under cardiologists who are experienced implanters of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds). \nThere are two patient groups in the study: Group A consists of patients implanted with a device from the Ilivia ICD Family; Group B consists of patients implanted with a Plexa ICD Lead. Some patients will receive both types of device as components of their implanted ICD system; those patients will belong to both groups, A and B.\nPotential participants will already have an indication for the implantation of an ICD or CRT-D system. By consenting to participate, patients agree to receive the specific model/s of device/s, and to have their clinical/technical data collected over 6 months and analysed for the study. The required visits, at pre-hospital discharge, 3 months and 6 months, are accommodated within the standard follow-up regimes of the participating sites.\nSome device settings are required by the protocol in order to collect the necessary data, but may be altered in cases where the patient has a particular clinical need.\n\n
REC name
North West - Preston Research Ethics Committee
REC reference
16/NW/0692
Date of REC Opinion
27 Sep 2016
REC opinion
Favourable Opinion