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

Use our guide to learn which trials are right for you!

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).


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
sites
Oklahoma City, Oklahoma 73120
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
?
mi
from
Providence, RI
Click here to add this to my saved trials
1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
?
mi
from
Abington, PA
Click here to add this to my saved trials
Albuquerque, New Mexico 87102
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Ann Arbor, Michigan 48106
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Athens, Georgia 30606
?
mi
from
Athens, GA
Click here to add this to my saved trials
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
Augusta, Georgia 30912
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Avondale, Arizona 85392
?
mi
from
Avondale, AZ
Click here to add this to my saved trials
Baltimore, Maryland 21237
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
1055 N Curtis Rd
Boise, Idaho 83706
(208) 367-2121
Saint Alphonsus Regional Medical Center Saint Alphonsus Health System is a four-hospital regional, faith-based Catholic...
?
mi
from
Boise, ID
Click here to add this to my saved trials
506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Burlington, Vermont 05405
?
mi
from
Burlington, VT
Click here to add this to my saved trials
Camp Hill, Pennsylvania 17011
?
mi
from
Camp Hill, PA
Click here to add this to my saved trials
Canton, Ohio 44710
?
mi
from
Canton, OH
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Columbus, Ohio 43214
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
508 Fulton Street
Durham, North Carolina 27705
919-286-0411
Durham VA Medical Center Since 1953, Durham Veterans Affairs Medical Cetner has been improving the...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Falls Church, Virginia 22042
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
1400 29th Street South
Great Falls, Montana 59405
406-454-2171
Great Falls Clinic Founded in 1917, the Great Falls Clinic is the fourth oldest medical...
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Knoxville, Tennessee 37920
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Largo, Florida 33770
?
mi
from
Largo, FL
Click here to add this to my saved trials
Lees Summit, Missouri 64086
?
mi
from
Lees Summit, MO
Click here to add this to my saved trials
Littleton, Colorado 80120
?
mi
from
Littleton, CO
Click here to add this to my saved trials
Long Beach, California 90801
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90017
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90048
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Lynchburg, Virginia 24501
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Marshfield, Wisconsin 54449
?
mi
from
Marshfield, WI
Click here to add this to my saved trials
Mesa, Arizona 85206
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
Midland, Michigan 48670
?
mi
from
Midland, MI
Click here to add this to my saved trials
259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Newport Beach, California 92663
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Port Charlotte, Florida 33952
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
Roanoke, Virginia 24033
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
Sacramento, California 95819
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Saginaw, Michigan 48601
?
mi
from
Saginaw, MI
Click here to add this to my saved trials
Stony Brook, New York 11794
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Takoma Park, Maryland 20912
?
mi
from
Takoma Park, MD
Click here to add this to my saved trials
Victoria, British Columbia
?
mi
from
Victoria,
Click here to add this to my saved trials
Warwick, Rhode Island 02886
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Wormleysburg, Pennsylvania 17043
?
mi
from
Wormleysburg, PA
Click here to add this to my saved trials
Zephyr Hills, Florida 33542
?
mi
from
Zephyr Hills, FL
Click here to add this to my saved trials