PRAETORIAN-DFT
Research type
Research Study
Full title
A Prospective Randomised CompArative trial of SubcutanEous ImplanTable CardiOverter-DefibrillatoR ImplANtation with and without DeFibrillation Testing
IRAS ID
248861
Contact name
Pier Lambiase
Contact email
Sponsor organisation
AMC Medical Research BV
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
64634, ABR form (Netherlands)
Duration of Study in the UK
5 years, 4 months, 0 days
Research summary
During the implantation of an S-ICD, the functions of the ICD are always tested. A defibrillation test (DFT) also takes place in most cases. A defibrillation test tests the operation of the S-ICD. This is done by inducing a cardiac arrhythmia. If the S-ICD is working properly, it will give a shock and the normal heart rhythm will be restored. Research has shown that in most cases a defibrillation test during S-ICD implantation is successful. During the implantation of a transvenous ICD, in which the guidewires run through the blood vessels, this test is no longer performed since large comparative research has shown that performing a defibrillation test in this group has no benefit. We want to investigate whether we can implant an S-ICD without performing a defibrillation test because performing a defibrillation test involves a (very small) risk of complications. As an alternative, instead of this test, we want to perform an extra check on the X-rays taken after the implantation. These X-rays are taken by default after S-ICD implantation. We think that with this extra check of the X-rays, we can check whether the S-ICD is correctly implanted just as well or better.
REC name
London - South East Research Ethics Committee
REC reference
18/LO/1492
Date of REC Opinion
12 Nov 2018
REC opinion
Further Information Favourable Opinion