Atrial Fibrillation Clinical Trial
— AJUAROfficial title:
Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias
Verified date | January 2010 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
The study evaluates 3 different populations:
It is an open, randomized, parallel-group study comparing the effectiveness of intravenous
(iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of :
1. recent-onset atrial fibrillation versus iv flecainide
2. sustained monomorphous ventricular tachycardia versus iv procainamide
The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline
versus iv flecainide in the diagnosis of Brugada syndrome
Status | Completed |
Enrollment | 123 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 80 Years |
Eligibility |
Inclusion Criteria: - AF: Patients with isolated, idiopathic, sustained, symptomatic, recent onset(>10 minutes to <24 hours) atrial fibrillation. - VT: Patients with ventricular tachycardia with good haemodynamic tolerability attending the emergency room or induced at the electrophysiology lab during testing for ventricular arrhythmias. - Brugada Sd (BrS): First-degree relatives of a patient with Brugada Syndrome with a ECG non-diagnostic of the BrS. Exclusion Criteria: - General: Pregnancy - AF: Pre-existing heart disease. - Secondary AF - 2nd and 3rd degree AV block or RBBB associated with LAFB or LPFB (bifascicular block). - LVF<40%. - Moderate-severe liver failure. - AF with haemodynamic compromise. - VT:VT with haemodynamic compromise. - BrS:Pre-existing heart disease. - 2nd and 3rd degree AV block or RBBB associated with LAFB or LPFB (bifascicular block). - Moderate-severe liver failure. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Servicio de Cardiología, Hospital Clínic | Barcelona | |
Spain | Hospital Donostia | Donostia | Guipuzcoa |
Spain | Hospital Puerta de Hierro | Madrid | |
Spain | Hospital La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with reversion of atrial fibrillation | 1 hour | No | |
Primary | Proportion of patients with reversion of ventricular tachycardia | 15 min | No | |
Primary | Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test. | 1 hour | No |
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