Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02344277
• Date of registration: 16/01/2015
• Prospective Registration: Yes
• Primary sponsor: Nantes University Hospital
• Public title: Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients S-ICD Brugada
• Scientific title: Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients
• Date of first enrolment: May 12, 2015
• Target sample size: 130
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02344277
• Study type: Observational

Countries of recruitment

Denmark, France, Germany, Italy, Spain

Contacts

• Name: Vincent PROBST, Pr
• Affiliation: Nantes University Hospital

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Brugada Syndrome

S-ICD System (Implantable Defibrillator)

Intervention(s)

Device: S-ICD System (implantable defibrillator)

Primary Outcome(s)

appropriate number of shocks to the number of shocks recorded at 5 years after S-ICD implantation [Time Frame: 5 years]

Secondary Outcome(s)

annual rate of inappropriate shocks [Time Frame: 5 years]

Secondary ID(s)

RC14_0238

Source(s) of Monetary Support

Please refer to primary and secondary sponsors