Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. (NODE-303)

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Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. (NODE-303)

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The NODE-303 Study: Multi-Centre, Multi-National,Open Label, Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia.

clinicaltrials.gov

Eligibility

Inclusion Criteria

– Has been diagnosed with PSVT by a medical professional, and reports ≥ 1 previous episode of PSVT
– ≥ 18 years of age;

Exclusion Criteria

– Had only a history of atrial arrhythmia that does not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g. atrial fibrillation, atrial flutter, intra-atrial tachycardia)
– History of allergic reaction to verapamil
– Current therapy with digoxin, or any Class I or III anti-arrhythmic drug. (The only exception is amiodarone)
– History of syncope due to an arrhythmic etiology at any time, or history in last 5 years of unexplained syncope
– Evidence of renal dysfunction as determined by an estimated glomerular filtration (eGFR) rate:
<60mL/min for patients <60 years of age; <40mL/min for patients ≥60 and <70 years of age <35mL/min for patients ≥70 years of age

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