Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hospital Clinic of Barcelona
- Enrollment
- 123
- Locations
- 4
- Primary Endpoint
- Proportion of patients with reversion of atrial fibrillation
Study Overview
Brief Summary
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 :
- recent-onset atrial fibrillation versus iv flecainide
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
A
IV flecainide in atrial fibrillation
Intervention: flecainide (Drug)
B
IV ajmaline in atrial fibrillation
Intervention: ajmaline (Drug)
c
iv procainamide in ventricular tachycardia
Intervention: procainamide (Drug)
d
iv ajmaline in ventricular tachycardia
Intervention: ajmaline (Drug)
e
iv flecainide in diagnosis of Brugada Sd
Intervention: flecainide (Drug)
f
iv ajmaline in diagnosis of Brugada Sd
Intervention: ajmaline (Drug)
Outcomes
Primary Outcomes
Proportion of patients with reversion of atrial fibrillation
Time Frame: 1 hour
Proportion of patients with reversion of ventricular tachycardia
Time Frame: 15 min
Proportion of subjects developing EKG pattern diagnostic of Brugada Sd. after provocation test.
Time Frame: 1 hour
Secondary Outcomes
No secondary outcomes reported