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
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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185 Cambridge Street
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330 Brookline Ave
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Los Angeles, California 90095
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1 Gustave L Levy Pl # 504
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13001 E. 17th Pl
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1100 N. Lindsay
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3451 Walnut St
Philadelphia, Pennsylvania 19104
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