Antiarrhythmics or Ablation for Ventricular Tachycardia 2

Completed · Phase 4

Conditions studied: Ventricular Tachycardia (VT)

In brief

A multicenter, randomized clinical trial to assess whether catheter ablation or antiarrhythmic drug therapy provides the most effective control of important clinical outcomes for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia (VT).

Key facts

Study ID

NCT02830360

Run by

John Sapp

People needed

416

Starts

2016-10-01

Expected to finish

2024-06-30

Last updated by the study team

2024-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior Myocardial Infarction and
• One of the following VT events while not being treated with amiodarone, sotalol, or another class I or class III antiarrhythmic drug) within the last 6 months:
• Sustained monomorphic VT documented on 12-lead ECG or rhythm strip terminated by pharmacologic means or DC cardioversion
• ≥3 episodes of VT treated with antitachycardia pacing (ATP), at least one of which was symptomatic
• ≥ 5 episodes of VT treated with antitachycardia pacing (ATP) regardless of symptoms
• ≥1 appropriate ICD shocks,
• ≥3 VT episodes within 24 hours

You may not qualify if…

• Unable or unwilling to provide informed consent.
• Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days, coronary revascularization (<90 days bypass surgery, <30 days percutaneous coronary intervention), or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.
• Are ineligible to take the antiarrhythmic drug to which they would be assigned due to allergy, intolerance or contraindication
• Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves
• Have had a prior catheter ablation procedure for VT
• Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF)
• Are in renal failure (Creatinine clearance <15 mL/min), have NYHA Functional class IV heart failure, or a systemic illness likely to limit survival to <1 year
• Have had recent ST elevation myocardial infarction or non-ST elevation MI (< 30 days); note that biomarker elevation alone after ventricular arrhythmias does not denote MI.
• Are pregnant.

Where it is running

• Hartford General Hospital — Hartford, Connecticut, United States
• Vanderbilt University Hospital — Nashville, Tennessee, United States
• Foothills Hospital — Calgary, Alberta, Canada
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Interior Health Authority — Kelowna, British Columbia, Canada
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• Royal Jubilee Hospital — Victoria, British Columbia, Canada
• Nova Scotia Health Authority — Halifax, Nova Scotia, Canada
• Hamilton Health Sciences Center — Hamilton, Ontario, Canada
• Queen's University Health Sciences Centre — Kingston, Ontario, Canada
• St. Mary's Hospital — Kitchener, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Montreal Heart Institute — Montreal, Quebec, Canada
• Centre Hospitalier de l'Universitaire de Montreal — Montreal, Quebec, Canada
• McGill University Health Center — Montreal, Quebec, Canada
• Sacre-Coeur Hospital — Montreal, Quebec, Canada
• Institut Universitaire de cardiologie et pneumologie de Quebec - Laval University Hosptial — Québec, Quebec, Canada
• Centre Hospitalier Universitaire de Sherbrooke — Sherbrooke, Quebec, Canada
• Hopitaux de Bordeaux — Bordeaux, Acquitaine, France
• CHU - University Hospital Nancy — Nancy, Meurthe-et-Moselle, France

Full record on ClinicalTrials.gov

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