Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
The primary objective of this study is to evaluate the effect of eleclazine (GS-6615)
 compared to placebo on the overall occurrence of appropriate implantable
 cardioverter-defibrillator (ICD) interventions (antitachycardia pacing [ATP] or shock) in
 adults with ICD or cardiac resynchronization therapy-defibrillator (CRT-D).
Key Inclusion Criteria:

 -  Have an ICD or CRT-D implanted for primary or secondary prevention and at least one
 ICD intervention for ventricular tachycardia/ventricular fibrillation (VT/VF) [shock
 or ATP] within 60 days prior to screening or a documented VT/VF episode (prior to
 implantation) within 60 days prior to screening

 -  Use of highly effective contraception methods if female of childbearing potential or
 sexually active male

 -  Must be hemodynamically stable

 Key Exclusion Criteria:

 -  New York Heart Association (NYHA) Class IV heart failure

 -  Myocardial infarction, unstable angina, coronary artery bypass graft (CABG) surgery or
 percutaneous coronary intervention (PCI) within 4 weeks prior to screening or during
 the screening period before randomization

 -  Hemodynamically significant primary obstructive valvular disease

 -  History of congenital heart disease

 -  Inherited arrhythmia such as Brugada syndrome. Individuals with long QT syndrome Type
 3 (LQT-3) or hypertrophic cardiomyopathy (HCM) may be considered.

 -  Individuals who are being considered for cardiac transplantation and are on a cardiac
 transplant list

 -  History of seizures or epilepsy

 -  Cardiac ablation within 3 months prior to screening or planned cardiac ablation during
 the study

 -  Severe renal impairment

 -  Abnormal liver function tests

 -  Currently taking Class I and Class III antiarrhythmic drugs; such medications should
 be discontinued 5 half-lives (or 28 days for chronic use of amiodarone) prior to
 randomization

 -  Currently taking drugs or products that are strong inhibitors or inducers of CYP3A;
 such medications should be discontinued 5 half-lives prior to randomization

 -  Currently taking ranolazine; ranolazine should be discontinued at least 7 days prior
 to randomization

 -  Females who are pregnant or are breastfeeding

 -  Individuals with a subcutaneous ICD

 -  Body mass index (BMI) ≥ 36 kg/m^2

 Note: Other protocol defined Inclusion/Exclusion criteria may apply