EV ICD Pivotal Study
Research type
Research Study
Full title
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study
IRAS ID
270184
Contact name
Francis Murgatroyd
Contact email
Sponsor organisation
Medtronic Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
Implantable Cardioverter Defibrillator (ICD) therapy is indicated for patients at risk of sudden cardiac death due to life-threatening abnormal heart rhythms. ICD systems that consist of a device with a lead (thin electrical wire) threaded through the veins and into the heart are considered standard, but have some limitations. In addition, ICD systems are not suitable for patients in whom it is not possible or desired to enter the heart or the veins. Given this, there is demand for new ICD systems that preserve the heart and veins and avoid the potential disadvantages of standard ICD systems.
This new system consists of a lead between the breastbone and the heart, we call this approach “Extra Vascular”, and the system an Extravascular ICD. The EV ICD device would be placed on the left side of the chest between the skin and the ribs. Specifically designed tools are used to implant the EV ICD system.
Based upon extensive pre-clinical work and the EV ICD Pilot Study, the EV ICD Pivotal Study will evaluate the safety of the EV ICD system and how well the EV ICD system works in a clinical setting.
Patients who are at high risk of sudden cardiac death would be approached to see if they would consider being in the study.
Some heart rhythm disturbances are treated using catheters, sudden cardiac death is not a condition that responds well to this approach.
This study is being done at specialised hospitals that are used to treating this patient group. It is a Global study, with one hospital in the UK.
After the implant, patients will be followed at 2 weeks, 3 months and every six-months thereafter for up to 3.5 years. These visits may include study system testing, non-invasive information download from the study system, X-rays and questionnaires.REC name
London - Dulwich Research Ethics Committee
REC reference
19/LO/1838
Date of REC Opinion
3 Mar 2020
REC opinion
Further Information Favourable Opinion