The PRAETORIAN trial: Subcutaneous ICD versus Transvenous ICD
Research type
Research Study
Full title
The PRAETORIAN Trial: A prospective, randomised comparison of subcutaneous and transvenous implantable cardioverter defibrillator therapy
IRAS ID
135580
Contact name
Elijah Behr
Contact email
Sponsor organisation
AMC MEDICAL RESEARCH B.V.,
Clinicaltrials.gov Identifier
Research summary
Lay summary of study results: PRAETORIAN Study shows in a general ICD population that treatment with subcutaneous ICD is equally effective and safe as transvenous ICD with less lead complications
The subcutaneous implantable defibrillator (ICD) offers comparable performance in treating patients at risk of sudden cardiac death as the traditional transvenous ICD that has a lead in the heart, but gives less lead related complications. This is the outcome of the international PRAETORIAN trial: ICD-related complications were seen in 15.1% of patients with a subcutaneous ICD (S-ICD) versus 15.7% patients with a transvenous ICD (TV-ICD) after a median follow up of 4 years. Lead complications occurred in 6.6% of the patients with a TV-ICD, compared to 1.4% of the patients with a subcutaneous device. The PRAETORIAN trial is the first prospective randomized study to compare the two ICD types and the first to study the use of the S-ICD in a generalized ICD population. With this outcome it is now possible to make a better assessment of the preferred device for each patient with an ICD indication. The study was conducted in 39 centers in the Netherlands, Germany, Denmark, United Kingdom and the United States. Results were presented at HRS 2020 Science and are published in the prestigious journal The New England Journal of Medicine
REC name
London - South East Research Ethics Committee
REC reference
13/LO/1775
Date of REC Opinion
27 Nov 2013
REC opinion
Favourable Opinion