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NCT02830360CompletedPhase 4

Antiarrhythmics or Ablation for Ventricular Tachycardia 2

Ventricular Tachycardia Antiarrhythmics or AblatioN In Structural Heart Disease 2

Source: ClinicalTrials.gov · Last updated 1 Aug 2024

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
416 (actual)
First submitted
7 Jul 2016
Start date
1 Oct 2016
Primary completion date
6 Jun 2024
Lead sponsor
John Sapp
NCT number
NCT02830360

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 416
  • From 1 Oct 2016 to the primary completion date, 6 Jun 2024
  • 22 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have had a prior catheter ablation procedure for VT

Other illness

  • 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
  • Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF)
  • 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.

Lab values

  • 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

Other

  • Unable or unwilling to provide informed consent.
  • Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves
  • Are pregnant.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Foothills Hospital
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
University of Alberta Hospital
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Nova Scotia Health Authority
Coordinator of this site? Confirm its status
HalifaxCanadaUnknown status
Hamilton Health Sciences Center
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
Interior Health Authority
Coordinator of this site? Confirm its status
KelownaCanadaUnknown status
Queen's University Health Sciences Centre
Coordinator of this site? Confirm its status
KingstonCanadaUnknown status
St. Mary's Hospital
Coordinator of this site? Confirm its status
KitchenerCanadaUnknown status
London Health Sciences Centre
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LondonCanadaUnknown status
Centre Hospitalier de l'Universitaire de Montreal
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
McGill University Health Center
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MontrealCanadaUnknown status
Montreal Heart Institute
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Sacre Coeur Hospital
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
University of Ottawa Heart Institute
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Institut Universitaire de cardiologie et pneumologie de Quebec - Laval University Hosptial
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
Centre Hospitalier Universitaire de Sherbrooke
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SherbrookeCanadaUnknown status
St. Michael's Hospital
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TorontoCanadaUnknown status
St. Paul's Hospital
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VancouverCanadaUnknown status
Royal Jubilee Hospital
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VictoriaCanadaUnknown status
Hopitaux de Bordeaux
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BordeauxFranceUnknown status
CHU - University Hospital Nancy
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NancyFranceUnknown status
Hartford General Hospital
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HartfordUnited StatesUnknown status
Vanderbilt University Hospital
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.