Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
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
Clareo Health | Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
