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

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ClinicalTrials.gov Identifier: NCT02344277
Recruitment Status : Recruiting
First Posted : January 22, 2015
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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.


Condition or disease Intervention/treatment
Brugada Syndrome S-ICD System (Implantable Defibrillator) Device: S-ICD System (implantable defibrillator)

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients
Actual Study Start Date : May 12, 2015
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023



Intervention Details:
  • 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344277


Contacts
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Contact: Vincent PROBST, Pr 02.40.16.56.99
Contact: Aurélie THOLLET, INGENEER 02.40.16.52.79

Locations
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Denmark
Copenhagen University Hospital Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Jacob Tfelt - Hansen, Pr         
Principal Investigator: Jacob Tfelt-Hansen, Pr         
Gentofte University Hospital Not yet recruiting
Gentofte, Denmark, 2900
Contact: Michael Vinther, Pr         
Principal Investigator: Michael Vinther, Pr         
France
Bordeaux University Hospital Recruiting
Bordeaux, France, 33604
Contact: Frédéric SACHER, Pr    05.57.65.64.71      
Principal Investigator: Frédéric SACHER, Pr         
Brest University Hospital Recruiting
Brest, France, 29609
Contact: Jacques MANSOURATI, Pr    02.98.34.73.91      
Principal Investigator: Jacques MANSOURATI, Pr         
Grenoble University Hospital Recruiting
Grenoble, France, 38043
Contact: Pascal DEFAYE, PU-PH    04.76.76.54.37      
Principal Investigator: Pascal DEFAYE, Pr         
Lille University Hospital Not yet recruiting
Lille, France, 59037
Contact: Salem Kacet, Pr         
Principal Investigator: Salem Kacet, Pr         
Hospices Civils de Lyon Not yet recruiting
Lyon, France, 69394
Contact: Philippe CHEVALIER, Pr    04.72.35.70.27      
Principal Investigator: Philippe CHEVALIER, Pr         
AP-HM La Timone Recruiting
Marseille, France, 13005
Contact: Jean-Claude DEHARO, Pr    04.91.38.65.75      
Principal Investigator: Jean-Claude DEHARO, Pr         
Montpellier University Hospital Not yet recruiting
Montpellier, France, 34295
Contact: Pasquié Jean-Luc, Pr         
Principal Investigator: Pasquié Jean-Luc, Pr         
Nancy University Hospital Recruiting
Nancy, France, 54511
Contact: Hugues BLANGY, Pr    03.83.25.81.75      
Principal Investigator: Hugues BLANGY, Pr         
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Vincent PROBST, Pr    02.40.16.56.99      
Principal Investigator: Vincent PROBST, Pr         
AP-HP Hôpital BIchât Recruiting
Paris, France, 75018
Contact: Antoine LEENHARDT, Pr    01.40.25.77.92      
Principal Investigator: Antoine LEENHARDT, Pr         
Paris University Hospital - La pitié-Salpétrière Recruiting
Paris, France, 75651
Contact: Nicolas Badenco, Pr         
Principal Investigator: Nicolas Badenco, Pr         
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Philippe MABO, Pr    02.99.28.25.25      
Principal Investigator: Philippe MABO, Pr         
La Réunion University Hospital Recruiting
Saint-Pierre, France, 97448
Contact: Gaël CLERICI, Dr    +262 2 62 35 91 53      
Principal Investigator: Gaël CLERICI, Dr         
Strasbourg University Hospital Not yet recruiting
Strasbourg, France, 67091
Contact: Laurence JESEL-MOREL, Dr         
Principal Investigator: Laurence JESEL-MOREL, Dr         
Toulouse University Hospital Recruiting
Toulouse, France, 31059
Contact: Jean-Philippe MAURY, Dr    05.61.32.30.54      
Principal Investigator: Jean-Philippe MAURY, Dr         
Tours University Hospital Recruiting
Tours, France, 37044
Contact: Dominique BABUTY, Pr    02.47.47.46.50      
Principal Investigator: Dominique BABUTY, Pr         
Germany
University Medical Centre Mannheim Not yet recruiting
Mannheim, Germany, D-68 167
Contact: Martin BORGGREFE, Pr    +49 621 383 3024      
Principal Investigator: Martin BORGGREFE, Pr         
Italy
University of Turin Not yet recruiting
Turin, Italy, 10126
Contact: Fiorenzo Gaita, Pr         
Principal Investigator: Fiorenzo Gaita, Pr         
Spain
Hospital clinic de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Josep BRUGADA TERRADELLAS, Pr    +34 932 275 733      
Principal Investigator: Josep BRUGADA TERRADELLAS, Pr         
Hospital Puerta de Hierro Not yet recruiting
Majadahonda, Spain, 28222
Contact: Fernandez Lozano Ignacio, Dr         
Principal Investigator: Fernandez Lozano Ignacio, Dr         
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Vincent PROBST, Pr Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02344277     History of Changes
Other Study ID Numbers: RC14_0238
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

Keywords provided by Nantes University Hospital:
Subcutaneaous Implantable Cardiac Defibrillator
Brugada syndrome
Effectiveness
Safety

Additional relevant MeSH terms:
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Brugada Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Genetic Diseases, Inborn