Testing Etripamil NS for paroxysmal supraventricular tachycardia

Exclusion

• −Known hypersensitivity to verapamil or to any of the excipients of the study drug
• −Patients will be excluded from the study if they meet any of the following criteria:
• −History or presence of any of the following at the screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →:
• −Patients with a history of atrial arrhythmia that does not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, atrial tachycardia) are not eligible
• −Permanent junctional reciprocating tachycardia
• −Ventricular pre-excitation (e.g., delta wave on ECG, Wolff Parkinson White syndrome)
• −Second- or third-degree AV block
• −Sick sinus syndrome or clinically significant bradycardia (\<50 bpm or equivalent in this patient population) on the resting ECG
• −Ventricular tachycardia
• −Long QT syndrome
• −Major structural heart disease (e.g., Ebstein's anomaly, corrected congenital heart disease) or symptoms of congestive heart failure (New York Heart Association class II to IV).
• −Evidence of impaired liver function (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] \>3 x upper limit of normal for age and gender) at the Screening Visit
• −Evidence of End-Stage Renal Disease as determined by an estimated glomerular filtration rate assessed at the Screening Visit of \<15 mL/min/1.73m2, or requiring hemodialysis;
• −Treatment with any of the following that cannot or will not be discontinued during study participation:
• −Any investigational drug within 60 days prior to study drug administration
• −IV beta-adrenergic blocking drugs (e.g., propranolol, esmolol), calcium channel blocking drugs (e.g., verapamil, diltiazem) or amiodarone within 24 hours prior to study drug administration
• −Oral amiodarone within 30 days prior to study drug administration
• −Class I or III antiarrhythmic agents (e.g., flecainide, propafenone, sotalol) within five half-lives prior to study drug administration
• −Any other drug that has a contraindication with verapamil
• −Any other significant co-morbid condition that may have a negative impact on the patient's participation in the study or likely to result in non-compliance
• −History of hyperthyroidism
• −Current pregnancy or breastfeeding