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

Not Applicable

Terminated

Conditions: Ventricular Tachycardia

Interventions: Device: Biosense Webster's NAVI-STAR Thermo-Cool
Drug: amiodarone
Drug: sotalol

Registration Number: NCT01576042

Lead Sponsor: Duke University

Brief 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.

Detailed Description: This study will be conducted at up to 8 sites and will randomize 50 patients over 1 year to a strategy of catheter ablation (n=25) vs. state-of-the-art pharmacologic therapy (n=25). To be considered for enrollment in this pilot trial, patients must be at least 18 years of age and must have an ICD for a primary or secondary prevention indication, have ≥ 1 documented ICD shock or ≥ 3 ATP therapies for VT in the absence of a reversible cause that in the opinion of the treating physician requires further therapy and be eligible for both catheter ablation and at least 1 antiarrhythmic medication. Patients will be followed at 3 and 6 months and their vital status will be determined via a phone call at 12 months. Data on the safety and efficacy of therapies used in the pilot study will be collected. Of particular interest are adverse events resulting from the catheter ablation procedure and major side effects from antiarrhythmic medications.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 27

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter ablation	Biosense Webster's NAVI-STAR Thermo-Cool	The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults
Antiarrhythmic medication	amiodarone	The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
Antiarrhythmic medication	sotalol	The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death

Primary Outcome Measures

Name	Time	Method
Number of Participants Completed Month 3 Follow-Up	3 months	Records participants who completed Month 3 Follow-Up Visit

Secondary Outcome Measures

Name	Time	Method
Number of Participants Completed Month 6 Follow-Up	6 Months	Records participants who completed Month 6 Follow-Up Visit
Number of Participants Received Treatment Assigned	6 months	Records participants who received study randomized treatment during the study
Cardiovascular Hospitalizations	Baseline, 6 months	Records participants hospitalized for VT during the study
Number of Participants Remained on Randomized Treatment Assignment	6 month	Records participants who only received study treatment as randomized during the entire study
Number of Participants Switched to Other Arm	6 months	Records participants who received study treatment as randomized and later switched to other treatment arm during the study
Time to First Recurrent ICD Therapy for VT	Baseline, 6 months	Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT.
Number of Participants Had at Least One of the Efficacy Outcome Measurement	6 Months	Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT)

Trial Locations

Locations (5): Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Johns Hopkins Hospital
🇺🇸
Baltimore, Maryland, United States
Penn State Milton S. Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States