Arrhythmia, Tachycardia, Ventricular, Ventricular Fibrillation
Conditions
Keywords
Tachycardia, Ventricular, Ventricular Fibrillation, Defibrillators Implantable, Arrhythmia, Anti-arrhythmia agents
Brief summary
Primary objective: * to assess the efficacy of SSR149744C for the prevention of ventricular arrhythmia-triggered ICD interventions. Secondary objectives: * to assess versus placebo the tolerability of the different dose regimens of SSR149744C in the selected population. * to document SSR149744C plasma level during the study.
Interventions
DRUGSSR149744C
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with an ICD implanted during the previous year for documented spontaneous life-threatening ventricular arrhythmia OR implanted with an ICD and with at least one appropriate ICD therapy (shock or anti-tachycardia pacing) for ventricular tachycardia or ventricular fibrillation in the previous year. * Left ventricular ejection fraction measured by 2D-echocardiography must have been documented to be less than 40% in the last 6 months.
Exclusion criteria
MAIN CRITERIA (non-exhaustive list): * Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, conditions which increase the risk of severe antiarrhythmic drug side effects, severe associated conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is time to all ventricular tachycardia or ventricular fibrillation arrhythmia leading to any ICD intervention (anti-tachycardia pacing or ICD shock). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to all arrhythmia episodes leading to at least one documented ICD shock. | — |
Countries
Belgium, Canada, Czechia, Germany, Italy, Netherlands, Switzerland, United States
Outcome results
None listed