Evaluation of Subcutaneous Implantable Cardiac Defibrillator in Brugada Patients

NCT02344277 | Completed

• 1 other identifier: RC14_0238
• Study Type: observational
• Target: 130
• Locations: 5 countries
• Sites: 22

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.

Conditions

Brugada Syndrome; S-ICD System (Implantable Defibrillator)

Keywords

Subcutaneaous Implantable Cardiac Defibrillator; Brugada syndrome; Effectiveness; Safety

Outcome Measures

Primary Outcomes (1)

• appropriate number of shocks to the number of shocks recorded at 5 years after S-ICD implantation

  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 Outcomes (1)

• annual rate of inappropriate shocks

  5 years

Interventions

S-ICD System (implantable defibrillator) DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (22)

Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Gentofte University Hospital

Gentofte Municipality, 2900, Denmark

Location

Bordeaux University Hospital

Bordeaux, 33604, France

Location

Brest University Hospital

Brest, 29609, France

Location

Grenoble University Hospital

Grenoble, 38043, France

Location

Lille University Hospital

Lille, 59037, France

Location

Hospices Civils de Lyon

Lyon, 69394, France

Location

AP-HM La Timone

Marseille, 13005, France

Location

Montpellier University Hospital

Montpellier, 34295, France

Location

Nancy University Hospital

Nancy, 54511, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

AP-HP Hôpital BIchât

Paris, 75018, France

Location

Paris University Hospital - La pitié-Salpétrière

Paris, 75651, France

Location

Rennes University Hospital

Rennes, 35033, France

Location

La Réunion University Hospital

Saint-Pierre, 97448, France

Location

Strasbourg University Hospital

Strasbourg, 67091, France

Location

Toulouse University Hospital

Toulouse, 31059, France

Location

Tours University Hospital

Tours, 37044, France

Location

University Medical Centre Mannheim

Mannheim, D-68 167, Germany

Location

University of Turin

Turin, 10126, Italy

Location

Hospital clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Puerta de Hierro

Majadahonda, 28222, Spain

Location

MeSH Terms

Conditions

Brugada Syndrome

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Vincent PROBST, Pr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 22, 2015
• Study Start: May 12, 2015
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: April 29, 2019

Record last verified: 2019-04

Locations

FR (16); DE (1); DK (2); ES (2); IT (1)