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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
The dosage 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.
The choice and dosage 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.
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.
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
Number of Participants Completed Month 3 Follow-Up
Records participants who completed Month 3 Follow-Up Visit
Time frame: 3 months
Number of Participants Completed Month 6 Follow-Up
Records participants who completed Month 6 Follow-Up Visit
Time frame: 6 Months
Number of Participants Had at Least One of the Efficacy Outcome Measurement
Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT)
Time frame: 6 Months
Cardiovascular Hospitalizations
Records participants hospitalized for VT during the study
Time frame: Baseline, 6 months
Number of Participants Remained on Randomized Treatment Assignment
Records participants who only received study treatment as randomized during the entire study
Time frame: 6 month
Number of Participants Switched to Other Arm
Records participants who received study treatment as randomized and later switched to other treatment arm during the study
Time frame: 6 months
Time to First Recurrent ICD Therapy for VT
Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT.
Time frame: Baseline, 6 months
Number of Participants Received Treatment Assigned
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Records participants who received study randomized treatment during the study
Time frame: 6 months