ICONIC-M
Research type
Research Study
Full title
ICONIC-M: IMPROVING CRT OUTCOME WITH NON-INVASIVE CARDIAC MAPPING A multicentre randomised controlled study to assess patient response to CRT comparing ECGI map-guided left ventricular lead placement with empirical lead placement.
IRAS ID
319015
Contact name
Tim Betts
Contact email
Sponsor organisation
EP Solutions SA
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 31 days
Research summary
The purpose of this clinical investigation it to collect data with a non-invasive medical system, named ‘Amycard 01C’. The device will only contact the outside of the body.
The Amycard 01C-system is a CE-marked device approved and sold on the European and British markets. With the device, it is possible to see and map the function of the heart.
In this study, we look at how the Amycard 01C-system may help to further improve and optimise Cardiac Resynchronisation Therapy (CRT), compared to regular CRT.
As the data from the Amycard 01C-system can map the heart and better understand how it beats, it is hoped be able to place the pacemaker wires, which are part of a CRT device, more accurately.
If the pacemaker wires are placed more accurately, the CRT-therapy may be more effective.
In this study, it is hoped to demonstrate this effect.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
24/WM/0033
Date of REC Opinion
24 Apr 2024
REC opinion
Further Information Favourable Opinion