Antiarrhythmic Therapy Versus Catheter Ablation as First Line Treatment for AICD Shock Prevention: A Randomized Vanguard Pilot Trial
Overview
- Phase
- Phase 4
- Intervention
- Antiarrhythmic Drug Therapy
- Conditions
- Ventricular Tachycardia
- Sponsor
- Ottawa Heart Institute Research Corporation
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Appropriate ICD therapy
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to determine whether catheter based ablation is better than conventional anti-arrhythmic drug (AAD) therapy for reducing recurrent shocks in patients with an implantable cardioverter defibrillator (ICD). The second purpose of the study is to determine the safety of catheter-based ablation and the effect on quality of life of patients.
The study hypothesis is that catheter ablation is superior to AAD therapy in preventing recurrent ventricular arrhythmia in such subjects. This is a pilot trial which will provide data regarding recruitment potential and the feasibility of conducting a larger trial.
Detailed Description
AAD and catheter ablation have been shown to reduce the incidence of recurrent AICD shocks. The disadvantages of AAD include side effects from medications and the lack of compliance during long-term therapy. Previous trials have demonstrated the feasibility, safety and efficacy of catheter ablation as "first-line" treatment for reducing recurrent ventricular arrhythmia and AICD shocks in this subject population. However, these catheter ablation trials did not systematically compare the efficacy of catheter ablation with AAD therapy. While both treatment strategies have been shown to be effective in this setting it is unclear how they compare with each other in preventing AICD shocks. This is a single centre, parallel group, two-arm, unblinded randomized vanguard pilot trial comparing catheter ablation with AAD therapy for preventing recurrent AICD shocks. Eligible and consenting subjects will be equally randomized to receive either AAD therapy or a catheter ablation procedure. A 30-day treatment period will be provided to allow for adequate time to implement the two treatments. Subjects randomized to the antiarrhythmic therapy arm will receive clinically effective loading doses of either sotalol, mexiletine, procainamide or amiodarone (oral or IV) alone or in combination, as chosen by the study investigator. Subjects randomized to the catheter ablation arm will undergo the procedure within the 30 treatment period. Concomitant antiarrhythmic therapy with amiodarone or other AAD will be avoided if possible in the ablation group. However, AAD may be used to suppress ventricular arrhythmia resulting in AICD shocks or anti-tachycardia pacing (ATP) while waiting for the catheter ablation procedure. Subjects will be seen for a baseline randomization visit, then at 3, 6, 9 and 12 months after enrollment and every 3 months thereafter until the end of the study. Subjects will be followed up for a minimum of 12 months and a maximum of 24 months. Quality of life questionnaires will be done at each visit. Standard of care blood work, chest x-ray, and ECG will be done in the AAD arm depending on the AAD chosen as treatment. ICD programming will be standardized for all subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥ 18 and ≤ 85 years old
- •Able to provide informed consent
- •AICD implanted for primary prophylaxis against sudden cardiac death
- •AICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes
- •CAD with prior myocardial infarction (\>60 days prior to enrollment)
- •AICD or ECG documentation of ventricular arrhythmia responsible for appropriate AICD therapy (\> 3 ATP or ≥ 1 appropriate Shock)
Exclusion Criteria
- •Contraindication or allergy to contrast media, routine procedural medications or catheter materials
- •Contraindication to an interventional procedure
- •Current or previous (within 3 months) antiarrhythmic therapy
- •Absolute contraindication to amiodarone or other AAD
- •New York Heart Association (NYHA) functional class IV
- •Stroke within the past 90 days
- •Unstable angina
- •Hypertrophic cardiomyopathy, Non-ischemic dilated cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Catecholamine sensitive polymorphic VT or long QT syndrome
- •Subjects with active ischemia that are eligible for revascularization
- •Life expectancy less than 6 months
Arms & Interventions
Anti-arrhythmic drug therapy
Oral and/or intravenous loading doses of Sotalol, mexiletine, procainamide or amiodarone as first line therapy. Drug chosen is preference of the treating physician. May use single or combination of AAD. Loading doses as per standard dosing guidelines for VT. Subjects on amiodarone should receive oral maintenance dose of at least 200 mg/day.
Intervention: Antiarrhythmic Drug Therapy
Catheter ablation
Ventricular tachycardia (VT) Catheter ablation, using a standardized VT ablation procedure protocol.
Intervention: Catheter ablation
Outcomes
Primary Outcomes
Appropriate ICD therapy
Time Frame: After 30 day treatment period
Appropriate AICD therapy after the 30 day treatment period; defined as ≥ 1 appropriate Shock or ATP that needs further intervention in the form of catheter ablation or AAD therapy.
Secondary Outcomes
- Composite Safety Endpoint(Up to 24 months)