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Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia. The NODE-301 Trial.

The primary objective of this study is to determine whether etripamil nasal spray (NS) 70 mg is superior to placebo at terminating episodes of PSVT in an outpatient setting. Primary Outcome Measures: 1. The time to conversion of an episode of PSVT to sinus rhythm (SR) after study drug administration. [Time Frame: 10 months]. The primary efficacy endpoint is defined as an adjudicated termination of a positively adjudicated episode of PSVT (AV nodal reentrant tachycardia or AV reentrant tachycardia determination if possible) and conversion to sinus rhythm (SR) for at least 30 seconds. Secondary Outcome Measures: 1. Relief of specific symptoms ( i.e., heart palpitations, rapid pulse feeling, chest pain, anxiety, shortness of breath, dizziness, and fainting) potentially associated with an episode of PSVT. [Time Frame: 10 months]. 2. Rating of Treatment Satisfaction Questionnaire for Medication (TSQM). [Time Frame: 10 months] Other Outcome Measures: 1.The number of positively adjudicated episodes of PSVT terminated by a vagal maneuver (VM), [Time Frame: 10 months]. 2. The percentage of patients requiring additional medical intervention to terminate an episode of PSVT [Time Frame: 10 months]

Phase

III

Recruitment Status

Current Studies