Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy
NCT00905853 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260
Last updated 2016-07-11
Summary
This study will compare aggressive antiarrhythmic therapy to catheter ablation for ventricular tachycardia in patients who have suffered prior myocardial infarction. The purpose of this study is to evaluate the optimal management of patients presenting with recurrent VT and receiving ICD therapy in spite of first-line antiarrhythmic drug therapy. The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for recurrent VT.
Conditions
- Recurrent Ventricular Tachycardia
Interventions
- PROCEDURE
-
Catheter Ablation
Intracardiac electrode catheters are placed via central vasculature to identify myocardial scar, and surviving conduction channels within the scar which form the substrate for ventricular tachycardia. Radiofrequency energy is applied to these sites, interrupting the VT circuits.
- DRUG
-
Escalated Antiarrhythmic Therapy
Patients who have 'failed' antiarrhythmic therapy (except amiodarone) will be prescribed: Amiodarone 400 mg twice daily for 2 weeks, followed by 400 mg/day for 4 weeks, followed by 200 mg/day thereafter. Patients who 'failed' amiodarone (less than 300mg/day) will be prescribed: Amiodarone 400 mg three times a day for 2 weeks, followed by 400 mg/day for 1 week and 300 mg/day thereafter. Patients who 'failed' amiodarone (greater or equal to 300mg/day) will be prescribed: Amiodarone at the current dose with the addition of mexiletine 400 to 800 mg/day
Sponsors & Collaborators
-
Abbott Medical Devices
collaborator INDUSTRY -
Biosense Webster, Inc.
collaborator INDUSTRY -
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
John Sapp
lead OTHER
Principal Investigators
-
John L Sapp, BSc, MD, FRCPC · Nova Scotia Health Authority
-
Ratika Parkash, MD, MSc, FRCPC · Nova Scotia Health Authority
-
Anthony S Tang, MSc, MD, FRCPC · Royal Jubilee Hospital
-
George A Wells, BSc,MSc,PhD · Univeristy of Ottawa Heart Institute
-
William G Stevenson, MD · Brigham and Women's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- Canada
Study Locations
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