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

This is an interventional treatment trial for Paroxysmal Supraventricular Tachycardia focused on measuring PSVT Read More

Inclusion Criteria:

A patient will be eligible for study participation if they meet all of the following criteria:

1. 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 Supraventricular Tachycardia (SVT) that includes the atrioventricular (AV) node as a critical part of reentrant circuit.
2. Is at least 18 years of age;
3. Signed NODE-303 written informed consent
4. 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.
5. Willing and able to comply with study procedures

Exclusion Criteria:

A patient will be excluded from the study if they meet any of the following criteria:

1. 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.
2. History of allergic reaction to verapamil
3. 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 amiodarone which must be stopped 30 days before enrollment.
4. History or evidence of ventricular pre-excitation, e.g., delta waves, Wolff- Parkinson-White syndrome
5. History or evidence of a second- or third-degree AV block
6. History or evidence of severe ventricular arrhythmia (e.g., torsades de pointes, ventricular fibrillation, or sustained ventricular tachycardia).
7. Symptoms of congestive heart failure New York Heart Association Class II to IV
8. SBP < 90 mmHg at Screening, Baseline or any Follow-up Visit.
9. Severe symptoms of hypotension experienced during PSVT episodes.
10. 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
11. History of syncope due to an arrhythmic etiology at any time, or history in last 5 years of unexplained syncope
12. Is pregnant or breastfeeding
13. 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.
14. History of Acute Coronary Syndrome (ACS) or stroke within 6 months of screening

15. Evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the Screening Visit as follows:

    1. <60mL/min/1.73m2 for patients <60 years of age;
    2. <40mL/min/1.73m2 for patients ≥60 and <70 years of age
    3. <35mL/min/1.73m2 for patients ≥70 years of age