Last updated on May 2019

Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: S-ICD System (Implantable Defibrillator) | Brugada Syndrome
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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