Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:June 2012
End Date:September 2017
Contact:Karen Cropper
Phone:909-839-8607

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The purpose of this study is to determine if early ablation (i.e., ablation of ventricular
tachycardia in patients with infrequent VT episodes) is more effective than medical therapy
alone for the treatment of ischemic ventricular tachycardia in patients with Implantable
Cardioverter Defibrillators (ICDs) who continue to have episodes of ventricular tachycardia
despite drug therapy.


Inclusion Criteria:

1. Subject must be drug refractory on Class I-IV AADs (i.e., having VT episodes despite
drug therapy)

a. Subject must be on at least one AAD at time of enrollment

2. Qualifying episode must be sustained, monomorphic Ventricular Tachycardia post
myocardial infarction

3. ICD implanted

4. 1 to 3 sustained monomorphic VT episodes requiring appropriate therapy within the
previous six (6) months as determined by the investigator

5. History of myocardial infarction documented by the development of pathological Q
waves with or without symptoms, imaging evidence of a region of loss of viable
myocardium that is thinned and fails to contract in the absence of a nonischemic
cause, or pathological findings of a healed or healing myocardial infarction

6. 18 years or older

7. Able and willing to comply with all pre- and follow-up testing and requirements

8. Signed Informed Consent Form

Exclusion Criteria:

1. Age < 18 years

2. Documented intra-atrial or ventricular thrombus or other abnormality on preablation
echocardiogram

3. Patients with Incessant Ventricular Tachycardia (continuous sustained VTs that recur
promptly despite repeated intervention for termination over several (≥ 3) hours)

4. Contraindication to anticoagulation

5. NYHA class IV

6. Left ventricular assist devices (LVADs) or other circulatory assist devices

7. Stroke as confirmed by plasma d-dimer levels or acute myocardial infarction as
documented by electrocardiogram or cardiac imaging within the past three (3) months.
(Note that a small cardiac enzyme release resulting from being in VT/shocks/etc. is
not considered a myocardial infarction.)

8. Patients with active ischemia who are eligible for revascularization

9. Patients with idiopathic Ventricular Tachycardia or Ventricular Tachycardia of
non-ischemic cause (such as nonischemic cardiomyopathy)

10. Other disease process likely to limit survival to less than 12 months

11. Serum creatinine of ≥ 2.5mg/dl

12. Thrombocytopenia or coagulopathy

13. Prior ablation for Ventricular Tachycardia

14. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)

15. Enrollment in an study evaluating an investigational device or drug

16. Unable or unwilling to comply with protocol requirements

17. Exclusively Polymorphic Ventricular Tachycardia
We found this trial at
23
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1 Gustave L Levy Pl # 504
New York, New York 10029
 (212) 241-6500
Mount Sinai School of Medicine Icahn School of Medicine at Mount Sinai is proud to...
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1800 Orleans St
Baltimore, Maryland 21287
(410) 955-5000
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Los Angeles, California 90095
310-825-4321
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
The Florida Hospital Florida Hospital is one of the country’s largest not-for-profit health care providers...
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533 Parnassus Ave
San Francisco, California 94122
(415) 476-9000
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
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1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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Maywood, Illinois 60153
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Milwaukee, Wisconsin 53215
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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45 Castro Street
San Francisco, California 94114
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California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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San Francisco, California 94121
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