Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
75

Summary

Conditions
Ventricular Tachycardia (VT)
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Implantable Defibrillators (ICDs) reduce sudden death and can terminate some VT without shocks, but they don't prevent VT; the most appropriate strategy to suppress VT remains unknown. Two randomized clinical trials have suggested that catheter ablation can significantly reduce the incidence of subs...

Implantable Defibrillators (ICDs) reduce sudden death and can terminate some VT without shocks, but they don't prevent VT; the most appropriate strategy to suppress VT remains unknown. Two randomized clinical trials have suggested that catheter ablation can significantly reduce the incidence of subsequent VT in patients after an initial episode. Neither trial, however, compared catheter ablation to active antiarrhythmic drug therapy. Randomized trials of antiarrhythmic drug therapy have demonstrated that therapy with either sotalol or amiodarone can reduce recurrent VT. Both antiarrhythmic drug and ablation therapy suffer from imperfect efficacy and the potential for significant side-effects. No study has compared ablation to drug therapy for first-line treatment. The VANISH study which compared ablation to aggressive antiarrhythmic drug therapy for patients who have failed initial drug therapy was published in May 2016, and demonstrated that for patients with drug-refractory VT, catheter ablation was superior to escalation of antiarrhythmic drug therapy. Benefits were seen in the group which had VT despite amiodarone. Event rates were similar between amiodarone and sotalol for patients with VT occurring despite sotalol, who were randomized to either new initiation of amiodarone or catheter ablation. These results do not address the clinical question of the most appropriate first line therapy for suppression of VT in persons with prior myocardial infarction, an ICD and VT. The trial hypothesis is: catheter ablation will, in comparison to antiarrhythmic drug therapy reduce the composite outcome of death at any time, appropriate ICD shock after 14 days, ventricular tachycardia storm after 14 days or treated sustained ventricular tachycardia below the detection rate of the ICD for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia.

Tracking Information

NCT #
NCT02830360
Collaborators
  • Heart and Stroke Foundation of Canada
  • Abbott Medical Devices
  • Biosense Webster, Inc.
  • Ottawa Heart Institute Research Corporation
  • Canadian Institutes of Health Research (CIHR)
  • Cardiac Arrhythmia Network of Canada
  • Abbott
  • Nova Scotia Health Authority
Investigators
Principal Investigator: John L Sapp, MD FRCPC Nova Scotia Health Authority Study Director: Ratika Parkash, MD MSc FRCPC Nova Scotia Health Authoriry Study Director: Anthony L Tang, MD FRCPC London Health Sciences Centre Study Director: George A Wells, BSc MSc PhD Ottawa Heart Institute Research Corporation Study Director: William G Stevenson, MD Brigham and Women's Hospital Study Director: Jeff Healey, MD FRCPC Population Health Research Institute, McMaster University