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

Stopped early · Phase 4

Conditions studied: Ventricular Tachycardia, Ischemic

In brief

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.

Key facts

Study ID

NCT01557842

Run by

Biosense Webster, Inc.

People needed

15

Starts

2012-06-01

Expected to finish

2014-03-19

Last updated by the study team

2017-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Qualifying episode must be sustained, monomorphic Ventricular Tachycardia post myocardial infarction
• ICD implanted
• 1 to 3 sustained monomorphic VT episodes requiring appropriate therapy within the previous six (6) months as determined by the investigator
• 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
• 18 years or older
• Able and willing to comply with all pre- and follow-up testing and requirements
• Signed Informed Consent Form

You may not qualify if…

• Age < 18 years
• Documented intra-atrial or ventricular thrombus or other abnormality on preablation echocardiogram
• Patients with Incessant Ventricular Tachycardia (continuous sustained VTs that recur promptly despite repeated intervention for termination over several (≥ 3) hours)
• Contraindication to anticoagulation
• NYHA class IV
• Left ventricular assist devices (LVADs) or other circulatory assist devices
• 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.)
• Patients with active ischemia who are eligible for revascularization
• Patients with idiopathic Ventricular Tachycardia or Ventricular Tachycardia of non-ischemic cause (such as nonischemic cardiomyopathy)
• Other disease process likely to limit survival to less than 12 months
• Serum creatinine of ≥ 2.5mg/dl
• Thrombocytopenia or coagulopathy
• Prior ablation for Ventricular Tachycardia
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
• Enrollment in an study evaluating an investigational device or drug
• Unable or unwilling to comply with protocol requirements
• Exclusively Polymorphic Ventricular Tachycardia

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• San Francisco VA Medical Center — San Francisco, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Colorado, Denver — Aurora, Colorado, United States
• Florida Hospital — Orlando, Florida, United States
• Loyola University Chicago — Maywood, Illinois, United States
• Central Baptist Hospital — Lexington, Kentucky, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Columbia University- New York Presbyterian Hospital — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States
• St. Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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