Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia



Status:Terminated
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:2/14/2019
Start Date:November 2014
End Date:July 25, 2016

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Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) - G130132

To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™
ablation catheter system results in a superior clinical outcome compared to routine drug
therapy in subjects with documented Monomorphic Ventricular Tachycardia [MMVT] (both ischemic
and non-ischemic) while maintaining an acceptable safety profile.

Approximately 50 centers in the United States (US) will participate in the study. Additional
centers outside the US may be considered, as necessary. The anticipated enrollment duration
is 48-60 months.

Inclusion Criteria:

- Patient is receiving a new St.Jude Medical (SJM) Implantable Cardioverter
Defibrillator (ICD) or SJM Cardiac Resynchronization Therapy-Defibrillator (CRT-D)
implant, which has study required programing capabilities and is appropriate for
remote monitoring. Subjects who have received the ICD / CRT-D up to 90 days prior to
enrollment are also eligible.

- Patient who has a high risk of ICD shock as shown by at least one documented
Monomorphic VT (MMVT)** by one or more of the following:

Spontaneous MMVT or Inducible MMVT during electrophysiology (EP) Study or Inducible MMVT
during Non-Invasive Programmed Stimulation (NIPS) Study

- 18 to 75 years of age

- Patient has been informed of the nature of the study and has agreed to its provisions
and provided written informed consent approved by the Institutional Review Board.

- Note Pleiomorphic ventricular tachycardia (VT) (multiple MMVT morphologies) is
acceptable but polymorphic VT or ventricular fibrillation (VF) is not.

Exclusion Criteria:

- Any history of stroke

- S-T elevation myocardial infarction (MI) or previous cardiac surgery within 60 days
prior to enrollment

- Patient is pregnant or nursing

- Patient has New York Heart Association (NYHA) class IV heart failure

- Patient has incessant ventricular tachycardia (VT) necessitating immediate treatment
(Patients with Incessant VT have continuous sustained VTs that recur promptly despite
repeated intervention for termination over several (≥3) hours)

- Patient has VT/VF thought to be from channelopathies

- Limited life expectancy (less than one year) according to Investigator

- Patient has current class IV angina

- Recent coronary artery bypass graft (CABG < 60 days) or percutaneous coronary
intervention (PCI < 30 days)

- Patient is currently participating in another investigational drug or device study

- Patient is unable or unwilling to cooperate with the study procedures

- Known presence of intracardiac thrombi (i.e., positive Transesophageal Echocardiogram
(TEE) for LA or LV clot). TEE is required for history of left atrium (LA) or left
ventricle (LV) clot and recommended for history of atrial fibrillation (AF) with CHADS
> 1

- Prosthetic mitral or aortic valve

- Mitral or aortic valvular heart disease requiring immediate surgical intervention

- Major contraindication to anticoagulation therapy or coagulation disorder

- Left Ventricular Ejection Fraction < 15%

- Patient has had a previous ablation procedure for ventricular tachycardia (VT),
excluding remote (> 3 months) outflow tract tachycardia

- Patient has glomerular filtration rate (GFR) < 30 mL/min/1.73m2 within the past 3
months

- Patient has peripheral vascular disease that precludes LV access

- Patient has a premature ventricular contraction (PVC) or VT induced cardiomyopathy
that is expected to resolve with ablation and will not require an ICD

- Patient has reversible cause of VT

- Use of left ventricular assist device (LVAD) or Tandem Heart devices (Impella and
Balloon pumps are acceptable)

- There is a strong clinical reason to believe that, in the opinion of the investigator,
the patient only has septal scar that is deep
We found this trial at
31
sites
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Adelaide,
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Baltimore, Maryland 21287
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Charlotte, North Carolina 28203
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Houston, Texas 77030
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Kansas City, Kansas 66160
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Los Angeles, California 90095
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Los Angeles, California 90033
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Nashville, Tennessee 37232
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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New York, New York 10029
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New York, New York 10016
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Rochester, Minnesota 55905
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Saint Louis, Missouri 63110
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Saint Louis, Missouri 63141
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34800 Bob Wilson Drive
San Diego, California 92103
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San Francisco, California 94143
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Staten Island, New York 10305
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The Woodlands, Texas 77380
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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