To perfom defibrillation threshold testing(DFT) or not to perform DFT?
Research type
Research Study
Full title
Implantable-Cardioverter Defibrillator and Cardiac Resynchronisation Therapy Generator Replacement with and without Intraoperative Defibrillation Threshold Testing.
IRAS ID
158160
Contact name
Eleanor Tesh
Contact email
Sponsor organisation
Newcastle University
Duration of Study in the UK
0 years, 7 months, 26 days
Research summary
Implantable cardioverter defibrillators (ICD) have vastly decreased the incidence of sudden cardiac death when compared to medical therapy alone. These devices omit a voltage shock to the heart when dangerous sustained cardiac rhythms occur, specifically ventricular arrhythmias. ICD’s are often combined with cardiac resynchronisation therapy (CRT-D) devices in cases of severe heart failure, in order to improve the efficiency of the heart the pump blood and ultimately prolong survival. During ICD implantation performing a defibrillation threshold (DFT) test requires the induction of ventricular arrhythmias, to test the sensing and shocking function of the implantable device. This aims to check appropriate device function. Retrospective and prospective studies have failed to confirm any benefit of DFT testing and this remains the standard of care during ICD implantation despite there being no formal guidelines. Furthermore the safety of routine DFT testing has been questioned as several adverse cardiovascular events have been attributed to the test during ICD insertion. The aim of the proposed study is to retrospectively compare the individual clinical outcomes of every patient that have received new and generator replacement ICD and CRT-D devices with and without intraoperative DFT testing in one single NHS centre. This will indicate whether there is any clinical necessity for this test for the implantable cardiac devices population as a whole. The retrospective nature means that no patient participation is necessary during the course of this study, which will be a 7 month period.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
14/YH/1261
Date of REC Opinion
27 Nov 2014
REC opinion
Favourable Opinion