APOLLO Version 1.0
Research type
Research Study
Full title
SAFETY AND PERFORMANCE OF INVICTA VENTRICULAR DF4 LEADS WITH ACTIVE FIXATION
IRAS ID
284519
Contact name
Badrinathan Chandrasekaran
Contact email
Sponsor organisation
Sorin CRM SAS/MicroPort CRM
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CIV-PT-20-07-033804, Eudamed
Duration of Study in the UK
4 years, 0 months, 28 days
Research summary
The aim of this study is to evaluate the safety and the electrical performance of the INVICTA lead that is to be used with an ICD (Implantable Cardioverter Defibrillator) or a CRT-D (Implantable Cardiac Resynchronisation Therapy Device).
The lead is positioned in the right ventricle, one of the large lower chambers of the heart, and is connected to the generator of the ICD or CRT-D, and the latest industry standard connector called a DF4. The DF4 connection reduces the bulkiness of the connection by having one port instead of the previous three. This has the advantage of an easier connection process for the implanter and reduction in the bulk of the device is potentially more comfortable for the patient and may reduce the time spent at the implantation procedure. The clinical data will be used to support the application to the CE marking of the INVICTA lead and to assess its long term electrical performances. The electrical performances will be assessed at implant, within the following 14 days, and then at 1,3,6,12,18 and 24 months post implant. There are four models of the INVICTA lead one with a single defibrillator coil (the part of the lead that delivers the therapy to the patient) and one with two defibrillator coils. Each of those are available in 58cm and 68cm lengths.REC name
South East Scotland REC 02
REC reference
21/SS/0011
Date of REC Opinion
2 Mar 2021
REC opinion
Further Information Favourable Opinion