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
- Diseases
- Coronary artery disease
- 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
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Foothills Hospital Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Nova Scotia Health Authority Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Hamilton Health Sciences Center Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Interior Health Authority Coordinator of this site? Confirm its status | Kelowna | Canada | Unknown status |
| Queen's University Health Sciences Centre Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| St. Mary's Hospital Coordinator of this site? Confirm its status | Kitchener | Canada | Unknown status |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Centre Hospitalier de l'Universitaire de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill University Health Center Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Sacre Coeur Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Institut Universitaire de cardiologie et pneumologie de Quebec - Laval University Hosptial Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Centre Hospitalier Universitaire de Sherbrooke Coordinator of this site? Confirm its status | Sherbrooke | Canada | Unknown status |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Royal Jubilee Hospital Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
| Hopitaux de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHU - University Hospital Nancy Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| Hartford General Hospital Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Vanderbilt University Hospital Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.