NCT02344277: S-ICD Brugada

Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

Completed Last updated 29 April 2019

What this trial tests

trial testing S-ICD System (implantable defibrillator) in Brugada Syndrome in 130 participants. Completed in 25 April 2019.

Timeline

12 May 2015

Primary endpoint
25 April 2019

25 April 2019

Quick facts

Lead sponsor	Nantes University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	130
Start date	12 May 2015
Primary completion	25 April 2019
Estimated completion	25 April 2019
Sites	22 locations across Denmark, France, Italy, Germany, Spain

Drugs / interventions tested

• S-ICD System (implantable defibrillator)

Conditions studied

• Brugada Syndrome — all drugs for Brugada Syndrome →
• S-ICD System (Implantable Defibrillator) — all drugs for S-ICD System (Implantable Defibrillator) →

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Brugada Syndrome or S-ICD System (Implantable Defibrillator). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Brugada syndrome is an inherited arrhythmia syndrome with an increased risk of syncope and sudden death resulting from episodes of polymorphic ventricular tachychardia and fibrillation. Currently, there is no medical therapy for the Brugada syndrome and the only treatment available is the implantation of an ICD. There is no discussion on the interest of the ICD implantation in secondary prevention and in patients who experienced syncope but the best therapeutic is more difficult to draw in asymptomatic patients. Recently we demonstrated that in asymptomatic patients with a spontaneous type 1 aspect of Brugada syndrome, (i) there was a significant risk of ventricular arrhythmia, (ii) the problem of inappropriate shocks can be solve with a good ICD programming and (iii) the problem of lead failure remains the main problem in this young population very active and represent the main limitation to larger indication of ICD implantation in this population with a very long life expectancy as these patients had a normal life expectancy except the risk of ventricular arrhythmia.

In this context the S-ICD System (Boston Scientific Inc.) which is an implantable defibrillator technology that treats ventricular tachyarrhythmias using a subcutaneous pulse generator and electrode system rather than a transvenous lead system, represents a very attractive opportunity as it gives the possibility to protect the patients of the risk of ventricular arrhythmia with no risk of lead failure. However, as this is a new technology and as Brugada syndrome patients are a very specific population (very active patients, specific and changing over time ECG aspect that is at risk of T wave over sensing and high risk of SVT), it seems important to evaluate the effectiveness and the safety of S-ICD in this specific context.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Diagnosis, Risk Stratification, and Treatment of Brugada Syndrome.
   Steinfurt J, Biermann J, Bode C, Odening KE. · · 2015 · cited 15× · PMID 26157012 · DOI 10.3238/arztebl.2015.0394
2. Optimal Strategies for Mitigating Sudden Cardiac Death Risk in At-risk Patients with Structural Heart Disease.
   Boey E, Kojodjojo P. · · 2018 · cited 1× · PMID 32494485 · DOI 10.19102/icrm.2018.090204