Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
Condition: Ventricular Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Intervention: Eleclazine; Placebo to match eleclazine
Intervention description: Eleclazine tablets administered orally; Placebo to match eleclazine tablets administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: VT; VF; Ventricular Tachycardia; Ventricular Fibrillation; shock; ATP

Summary:

      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).
    

Eligibility criteria:

        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