Clinical Trials

Inclusion Criteria:

• Has been diagnosed with PSVT by a medical professional, and reports having at least one previous episode of PSVT. For clarity, PSVT refers to episodic SVT that includes the AV node as a critical part of reentrant circuit. 
• Is at least 18 years of age.
• Signed NODE-303 written informed consent.
• Women of child-bearing potential must be willing to use at least 1 form of contraception during the trial and must be willing to discontinue from the study should they become or plan to become pregnant. Postmenopausal females are defined as having amenorrhea for at least 12 months prior to Screening without an alternative medical cause.
• Willing and able to comply with study procedures.

Exclusion Criteria:

• Patients with 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) are not eligible. Patients with a history of these tachycardias who are also diagnosed with PSVT are eligible.
• History of allergic reaction to verapamil.
• Current therapy with digoxin, or any Class I or III antiarrhythmic drug. Patients may be eligible if these drugs are stopped at least five half-lives before the administration of etripamil NS. The only exception is oral amiodarone which must be stopped 30 days before enrollment.
• History or evidence of ventricular pre-excitation; e.g., delta waves, Wolff-Parkinson-White syndrome.
• History or evidence of a second- or third-degree AV block.
• History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or sustained ventricular tachycardia).
• Symptoms of congestive heart failure New York Heart Association Class II to IV.
• SBP < 90 mmHg at Screening, Baseline or any Follow-up Visit.
• Severe symptoms of hypotension experienced during PSVT episodes.
• Significant physical or psychiatric condition including alcoholism or drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of the patient, or impede the patient’s capacity to follow the study procedures.
• History of syncope due to an arrhythmic etiology at any time, or history in last 5 years of unexplained syncope.
• Is pregnant or breastfeeding.
• Previously enrolled in a clinical trial for etripamil and received study drug or participation in any clinical trial for other investigational products or medical devices within 30 days of Screening.
• History of ACS or stroke within 6 months of Screening.
• Evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the Screening Visit as follows:
  • < 60mL/min/1.73m^2 for patients < 60 years of age;
  • < 40mL/min/1.73m^2 for patients ≥ 60 and < 70 years of age;
  • < 35mL/min/1.73m^2 for patients ≥ 70 years of age.