Clareo Health | Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)
Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Forest Laboratories
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have an ICD implanted and a history of ventricular tachycardia, ventricular fibrillation, or an appropriate ICD therapy.
Have a left ventricular ejection fraction \<= 0.40
You may not be if
Have New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF) or have decompensated CHF at the time of randomization;
Have unstable angina pectoris or a myocardial infarction within 30 days of randomization;
Have a history of Torsade de Pointes or heart transplantation
Have chronic atrial fibrillation or atrial fibrillation/flutter, that is not adequately rate controlled in the judgment of the Investigator, at screening;
Are currently taking systemic Class I or other Class III antiarrhythmic drugs
Are currently taking systemic drugs that prolong the QT interval
If female, are currently pregnant or breast feeding, or plan to become pregnant during the course of the study
