Pilot Study of Catheter Ablation for Ventricular Tachycardia in Patients With an Implantable Cardioverter Defibrillator

Stopped early · Not applicable

Conditions studied: Ventricular Tachycardia

In brief

The purpose of this pilot trial is to determine the feasibility of a large, multi-center randomized clinical trial aimed to test whether a treatment strategy of percutaneous catheter ablation of ventricular tachycardia (VT) is superior to state-of-the-art pharmacologic therapy at reducing all-cause mortality in patients with an implantable cardioverter defibrillator (ICD) who receive therapy for VT in the absence of any reversible cause.

Key facts

Study ID

NCT01576042

Run by

Duke University

People needed

27

Starts

2012-05-01

Expected to finish

2014-05-01

Last updated by the study team

2014-10-16

Who can join

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

You may qualify if…

• Have an ICD with or without cardiac resynchronization therapy (i.e. CRT-D) for a primary or secondary prevention indication
• Have ischemic heart disease defined as the presence of wall motion abnormalities and documented coronary artery disease (one ≥ 70% stenosis in ≥ 1 major coronary artery)
• Have ≥ 1 documented ICD shock or ≥ 3 ATP therapies within 6 months before randomization for VT in the absence of a reversible cause that in the opinion of the treating physician requires further therapy. The VT has to be monomorphic and at a rate of ≤ 260 bpm.
• Be at least 18 years of age
• Be eligible for catheter ablation
• Have no history of intolerance or contraindication to at least 1 of the following antiarrhythmic medications: amiodarone, sotalol, and mexiletine.
• Exclusion:
• Patients who in the opinion of the treating physician should not receive additional therapy
• More than 30 days of amiodarone treatment in the past 3 months unless the patient has been on ≤ 200 mgs of amiodarone daily for atrial arrhythmias or premature ventricular contractions (PVCs) and the patient is eligible for a higher dose of amiodarone
• Incessant VT that necessitates immediate treatment
• Reversible causes of VT including but not limited to ischemia, decompensated HF, and electrolyte disturbances
• The presence of a contraindication to catheter ablation of VT (including the presence of a mobile ventricular thrombus; an acute MI, coronary revascularization, or a stroke in the preceding 30 days; unstable angina or NYHA class IV HF; a mechanical valve; or inability to receive anticoagulation or antithrombotic therapy)
• Patients with non-ischemic cardiomyopathy
• Patients with hypertrophic obstructive, restrictive, or infiltrative cardiomyopathy
• Patients with acute myocarditis, congenital heart disease, valvular disease likely to require surgery in the next 1 year, and/or inoperable obstructive valvular disease
• Patients with a heart transplant or who are expected to undergo cardiac transplantation within 12 months
• Patients with a left ventricular assist device
• Patients who are already on antiarrhythmic drug therapy (other than beta-blockers) for VT (patients will not be excluded if they are receiving antiarrhythmic drug therapy for atrial arrhythmias or PVCs if they are eligible for additional drug therapy for VT).
• Heritable arrhythmias or increased risk for torsade de pointes with class III drugs
• End stage renal disease requiring dialysis
• Estimated life expectancy of <1 year from a non-cardiac cause
• Women who are pregnant or who have childbearing potential and are not using a reliable method of contraception
• Inability to give informed consent

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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