Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients (S-ICD Brugada)

April 26, 2019 updated by: Nantes University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Copenhagen University Hospital
      • Gentofte, Denmark, 2900
        • Gentofte University Hospital
  • France
      • Bordeaux, France, 33604
        • Bordeaux university hospital
      • Brest, France, 29609
        • Brest University Hospital
      • Grenoble, France, 38043
        • Grenoble University Hospital
      • Lille, France, 59037
        • Lille University Hospital
      • Lyon, France, 69394
        • Hospices Civils de Lyon
      • Marseille, France, 13005
        • AP-HM La Timone
      • Montpellier, France, 34295
        • Montpellier University Hospital
      • Nancy, France, 54511
        • Nancy University Hospital
      • Nantes, France, 44093
        • Nantes University Hospital
      • Paris, France, 75018
        • AP-HP Hôpital Bichat
      • Paris, France, 75651
        • Paris University Hospital - La pitié-Salpétrière
      • Rennes, France, 35033
        • Rennes University Hospital
      • Saint-Pierre, France, 97448
        • La réunion university hospital
      • Strasbourg, France, 67091
        • Strasbourg university hospital
      • Toulouse, France, 31059
        • Toulouse University Hospital
      • Tours, France, 37044
        • Tours university Hospital
  • Germany
      • Mannheim, Germany, D-68 167
        • University Medical Centre Mannheim
  • Italy
      • Turin, Italy, 10126
        • University of Turin
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Majadahonda, Spain, 28222
        • Hospital Puerta de Hierro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subjects selected for participation will be symptomatic or asymptomatic Brugada patients and, implanted or not with any ICD. Site investigators are responsible for screening. Subjects must meet all inclusion criteria. Subjects with any exclusion criteria will be excluded. The recruitment of the patients will be performed in a selected number of centers specifically involved in the management of patients affected by the Brugada syndrome in Europe and in which databases of patients are available.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
appropriate number of shocks to the number of shocks recorded at 5 years after S-ICD implantation
Time Frame: 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
annual rate of inappropriate shocks
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Vincent PROBST, Pr, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2015

Primary Completion (Actual)

April 25, 2019

Study Completion (Actual)

April 25, 2019

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC14_0238

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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