Status:
TERMINATED
DAPERB 3,4-DiAminoPyridine and Electrophysiological Response in Brugada Syndrome
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Brugada Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The Brugada syndrome is a rare disease potentially leading to severe arrhythmic events in otherwise healthy subjects.In many patients an Implantable cardiovertor defibrillator (ICD) is implanted to pr...
Detailed Description
Background: The Brugada syndrome is a rare disease potentially leading to severe arrhythmic events in otherwise healthy subjects.In many patients an Implantable cardiovertor defibrillator (ICD) is im...
Eligibility Criteria
Inclusion
- Man or woman ≥ 18 years old
- Brugada syndrome diagnosed with a type 1 ECG either spontaneous or drug-induced
- Electrophysiological study indicated for arrhythmic risk stratification purpose
- Inducibility of a sustained ventricular tachycardia (\> 30 seconds) or ventricular fibrillation requiring defibrillation
- Physical medical examination
- Signed written informed consent
Exclusion
- Personal or familial history of epilepsy
- Pregnancy
- Body weight \> 100 kg
- the need of \>1 counter shock for defibrillation
- Alcohol or cocaine consumption during the protocol
- Class I (with the exception of local anaesthesia by lidocaine), II, III and IV antiarrhythmic drugs, antidepressant drugs, ATP dependent potassium channel activators, sultopride not stopped for \> 7 halve-lives
- No medical insurance
Key Trial Info
Start Date :
September 12 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00701077
Start Date
September 12 2008
End Date
April 1 2010
Last Update
December 7 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lariboisière University Hospital - Cardiology department
Paris, France, 75010