Evaluating Ventricular Arrhythmia in Subjects With Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy-Defibrillator
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/21/2016 |
Start Date: | September 2014 |
End Date: | November 2016 |
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging, Parallel Group Study to Evaluate the Effect of GS-6615 on Ventricular Arrhythmia in Subjects With Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
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).
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).
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
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
We found this trial at
54
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Great Falls Clinic Founded in 1917, the Great Falls Clinic is the fourth oldest medical...
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Saint Alphonsus Regional Medical Center Saint Alphonsus Health System is a four-hospital regional, faith-based Catholic...
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New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Clearwater, Florida 33756
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Durham VA Medical Center Since 1953, Durham Veterans Affairs Medical Cetner has been improving the...
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Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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