Anti-arrhythmic Therapy vs Catheter Ablation as First Line Treatment for AICD Shock Prevention

• Status: Terminated
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Treatments: Amiodarone; Anti-Arrhythmia Agents; Mexiletine; Procainamide; Sotalol

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

• Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation

• Untreated hypothyroidism or hyperthyroidism. Subjects who are euthyroid on thyroid hormone replacement therapy are acceptable.

• Current enrollment in another investigational drug or device study.

• Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the Subject for the entire study period.

• Absolute contra-indication to the use of heparin and or warfarin.

• Documented intra-atrial thrombus, ventricular thrombus (< 6 months after detection of thrombus), tumor, or another abnormality, which precludes catheter introduction.

• Previous VT ablation

• Are pregnant.