Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

Brugada Syndrome Clinical Trial

— S-ICD Brugada  

Official title:

Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344277
• Other study ID #: RC14_0238
• Status: Completed
• Start date: May 12, 2015
• Est. completion date: April 25, 2019

Study information

• Verified date: April 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 25, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with type I Brugada syndrome eligible for implantation of an S-ICD system:

Symptomatic : (history of resuscitated sudden death, syncope) with an ECG showing an aspect of Brugada syndrome type I before or after pharmacological tests (ajmaline or flecainide test) according to the criteria of the consensus conference and after ECG validation by the Clinical Events Committee experts.

Asymptomatic: with an aspect of spontaneous type I Brugada syndrome after ECG validation by the Clinical Events Committee experts.

• Brugada syndrome patient with Indication for ICD replacement.

• No contra-indication for S-ICD implantation (anatomic or physiologic criteria) with particular attention to the validation of the ECG prescreening implantation. For this study at least 2 vectors must be suitable for S-ICD implantation.

• Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

• Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center.

Exclusion Criteria:

• Incessant ventricular tachycardia (VT) and/or documented spontaneous, frequently recurring VT that is reliably terminated with anti-tachycardia pacing.

• Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing.

• Presence of any severe medical condition such that the patient is not expected to survive for the planned study follow-up period.

• Minor, patient under trusteeship or under guardianship.

• Patients who currently participate in an investigational drug or device that clinically interferes with the S-ICD-Brugada registry study endpoints and results.

• Female of childbearing potential without adequate contraception at the time of the implantation.

• Inability to comply with the follow-up schedule.

Related Conditions & MeSH terms

• Brugada Syndrome
• S-ICD System (Implantable Defibrillator)

Intervention

Device:
• S-ICD System (implantable defibrillator)
The subjects will be symptomatic or asymptomatic Brugada patients with Indication for ICD replacement. Patients should be follow first at 1 month and then every 6 months according to the recent ACC/AHA/HRS guidelines60, for a period of 5 years until remote monitoring became available for S-ICD. Visit to 4 week post-implantation: Vital status, Clinical assessment data: weight; height; blood pressure; NYHA class, Exercise test will be performed to control sensing vectors during exercise, Electrocardiogram, Current cardiac medication, Device interrogation, Device programming, Save to USB pen drive data + Printouts Adverse events, Life quality evaluation form. Visit every 6 months post-implantation to 5 years follow-up visit: Vital status, Clinical status (e.g.NYHA) , Electrocardiogram , Current cardiac medication, Device interrogation, Device programming, Save to USB pen drive data + Printouts Adverse events, Life quality evaluation form, Current status of S-ICD system.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital	Copenhagen
Denmark	Gentofte University Hospital	Gentofte
France	Bordeaux University Hospital	Bordeaux
France	Brest University Hospital	Brest
France	Grenoble University Hospital	Grenoble
France	Lille University Hospital	Lille
France	Hospices Civils de Lyon	Lyon
France	AP-HM La Timone	Marseille
France	Montpellier University Hospital	Montpellier
France	Nancy University Hospital	Nancy
France	Nantes University Hospital	Nantes
France	AP-HP Hôpital BIchât	Paris
France	Paris University Hospital - La pitié-Salpétrière	Paris
France	Rennes University Hospital	Rennes
France	La Réunion University Hospital	Saint-Pierre
France	Strasbourg University Hospital	Strasbourg
France	Toulouse University Hospital	Toulouse
France	Tours University Hospital	Tours
Germany	University Medical Centre Mannheim	Mannheim
Italy	University of Turin	Turin
Spain	Hospital clinic de Barcelona	Barcelona
Spain	Hospital Puerta de Hierro	Majadahonda

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	appropriate number of shocks to the number of shocks recorded at 5 years after S-ICD implantation	The primary endpoint is the rate of successful appropriate shocks recorded at 5 years after S-ICD implantation in Brugada syndrome patients. In this population that will be a mix of symptomatic and asymptomatic patients, we anticipate a 1.5% per year event rate that will allow us to have a total of 15 patients receiving an appropriate shock at the end of the study.	5 years
Secondary	annual rate of inappropriate shocks	The secondary end point will be the annual rate of inappropriate shocks, the complications of S-ICD implantation and the complications during the follow-up.	5 years