REFINE ICD
Research type
Research Study
Full title
REFINE ICD
IRAS ID
135178
Contact name
D.J. Wright
Contact email
Sponsor organisation
Medtronic BRC
Clinicaltrials.gov Identifier
Research summary
The adoption of implantable cardioverter defibrillators (ICDs) into routine clinical practice has had a significant impact upon the treatment of life-threatening abnormally rapid heart rhythms (tachyarrhythmias). However, current means of assessing certain patients at risk and the potential survival benefits of receiving an ICD, requires further research. In particular, patients who have suffered a recent heart attack, but who have relatively good heart function, require further investigation. This group is the subject of the REFINE study.
The study, sponsored by Medtronic Inc., involves some 150 centres globally and will apply previous findings which demonstrated that two specific key measures of heart activity provide a sensitive and accurate means of identifying “at risk“ patients.
Based upon these findings, NHS patients who have suffered a heart attack within the last 2-15 months and who have a pre-defined level of heart function, will be invited to participate in the study. The study is anticipated to continue for around five years. Patients eligible to take part will all receive routine, standard medical care according to their needs. In addition to routine care, half of the patients will receive a market-released Medtronic ICD under standard procedures. Although the devices are all approved and are not experimental, the population in question has not yet been thoroughly studied and existing guidelines for the use of ICDs do not yet extend to this group. Under standard of care therefore, this patient group would not ordinarily receive an ICD. The purpose of the study is to investigate whether this particular population will gain a survival benefit by receiving an ICD and, as a consequence, assist clinicians in determining whether an ICD is an appropriate treatment for such patients.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/0183
Date of REC Opinion
24 Apr 2014
REC opinion
Favourable Opinion