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

• ClinicalTrials.gov Identifier: NCT02344277
• Recruitment Status: Completed
• First Posted: January 22, 2015
• Last Update Posted: April 29, 2019
• Sponsor: Nantes University Hospital
• Information provided by (Responsible Party): Nantes University Hospital

Tracking Information

• First Submitted Date: January 16, 2015
• First Posted Date: January 22, 2015
• Last Update Posted Date: April 29, 2019
• Actual Study Start Date: May 12, 2015
• Actual Primary Completion Date: April 25, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 22, 2015)

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.

Original Primary Outcome Measures (submitted: January 21, 2015)

rate of successful appropriate shocks [ 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.

Current Secondary Outcome Measures (submitted: January 21, 2015)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients
• Official Title: Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• 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.

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 30, 2019): 130
• Original Estimated Enrollment (submitted: January 21, 2015): 200
• Actual Study Completion Date: April 25, 2019
• Actual Primary Completion Date: April 25, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark, France, Germany, Italy, Spain

Administrative Information

• NCT Number: NCT02344277
• Other Study ID Numbers: RC14_0238
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nantes University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Nantes University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Nantes University Hospital
• Verification Date: April 2019