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

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Duke Clinical Research Institute
• Treatments: Amiodarone; Anti-Arrhythmia Agents; Sotalol

Criteria

Inclusion Criteria:

• 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