Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT02830360
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02830360
Study Brief:
Protocol Section:
NCT02830360