Conditions: Ventricular Arrhythmia
Keywords: VT VF Ventricular Tachycardia Ventricular Fibrillation shock ATP
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 313
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 3 mg daily as maintenance for up to approximately 20 months. arm 2: Participants will receive a single loading dose of eleclazine 30 mg on Day 1, followed by eleclazine 6 mg daily as maintenance for up to approximately 20 months. arm 3: Participants will receive a single loading dose of placebo to match eleclazine on Day 1, followed by placebo to match eleclazine once daily for up to approximately 20 months.

Interventions: intervention 1: Eleclazine intervention 2: Placebo to match eleclazine
Intervention descriptions: intervention 1: Eleclazine tablets administered orally intervention 2: Placebo to match eleclazine tablets administered orally

Protocol document: