Efficacy and Safety of Etripamil for the Termination of Spontaneous Paroxymal Supraventricular Tachycardia (PSVT). NODE 301 [Part 1 and Part 2 (RAPID Study)]

This is a two-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of etripamil nasal spray (NS) self-administered by patients who experience an episode of paroxysmal ventricular tachycardia (PSVT) in an at-home setting. Part 1 comprised the conduct of the NODE-301 study up to the date of the adjudication of 150th positively adjudicated PSVT episode and Part 2 comprises the conduct of the NODE-301 study after the completion of Part 1. The RAPID Study (NODE-301 - Part 2) will enroll patients enrolled during Part 1 who had not dosed with the double-blind study drug, or had not discontinued the study before the adjudication of the 150th positively adjudicated PSVT episode in Part 1, and patients enrolled into the study following the completion of Part 1. The study will continue for approximately 6 months after the date of the adjudication of the 180th positively adjudicated PSVT episode (the data on which the primary efficacy analysis of RAPID will be conducted). The study will include the following visits: A Screening Visit, A Test Dose Randomization Visit, Monthly Follow-up Visits, A Randomized Treatment Period, A Randomized Treatment Period Follow-Up Visit, An Open-Label Treatment Period, and A Final Study Visit.