Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303
Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia. NODE-303
NODE-303 is a multi-center, open label (OL) study to evaluate the safety of etripamil NS in
 patients with Paroxysmal Supraventricular Tachycardia (PSVT). Patients will be provided with
 an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be
 self-applied by the patient, when PSVT symptoms begin. Patients will self-administer
 etripamil NS if vagal maneuver is ineffective. After an episode of PSVT where drug is
 administered, the patient will return to the investigative site for a study visit and will be
 given the option to continue in NODE-303 and manage subsequent episodes of PSVT with
 etripamil NS.
NODE-303 is a multi-center, open label (OL) study to evaluate the safety of etripamil NS in
 patients with PSVT. Patients will be provided with an ambulatory Cardiac Monitoring System
 (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT
 symptoms begin. Patients will self-administer etripamil NS if vagal maneuver is ineffective.
 After an episode of PSVT where drug is administered, the patient will return to the
 investigative site for a study visit and will be given the option to continue in NODE-303 and
 manage subsequent episodes of PSVT with etripamil NS.

 The study will include:

 A Screening Visit during which the Investigator will verify that the patient meets the
 eligibility criteria of the NODE-303 study, will obtain the signed informed consent, take
 blood and urine for laboratory evaluations, and conduct other screening procedures. The
 informed consent for NODE-303 will be applicable for the initial and all subsequent PSVT
 episodes. A Baseline Visit during which the site will confirm eligibility, concomitant
 medications, train the patient on study procedures, and give the patient study drug, patient
 reported outcome (PRO) materials, and the CMS materials. A Treatment Period during which the
 patient will complete the monthly PRO survey, self-identify symptoms of PSVT, use the CMS,
 perform a vagal maneuver (VM), and self-administer etripamil NS if the symptoms do not
 resolve during or after the VM. Patients may be contacted during this period for reminders
 and training on what to do during a PSVT episode. Patients will also complete a per episode
 survey after any PSVT episode they experience. During the Treatment Period, Follow-up Visits
 will occur at the study site up to 14 days after each episode of PSVT which is treated with
 etripamil NS, and during which the Investigator will evaluate the results of the last usage
 of etripamil NS and decide whether the patient can continue in the study and receive a new
 study drug kit. A Final Study Visit that will occur when a patient discontinues or withdraws
 from the study, or when the overall study is completed, or the patient has completed the
 maximum number of doses. NODE-303 will continue until enough documented self-administrations
 of etripamil NS are included in the safety database to meet regulatory requirements for the
 etripamil NS development program. The common study end date (CSED) for the entire study will
 depend on the rate of accrual of the primary endpoint, unique patients with an episode. When
 the criteria for concluding the study have been met, the Sponsor will announce the common
 study end date (CSED) for the entire study and sites will be informed in advance to schedule
 all final patient visits prior to the CSED.
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

 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 of ventricular pre-excitation, e.g., delta waves, Wolff- Parkinson-White
 syndrome

 5. History of a second- or third-degree AV block

 6. Symptoms of congestive heart failure New York Heart Association Class II to IV

 7. 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

 8. History of syncope due to an arrhythmic etiology at any time, or history in last 5
 years of unexplained syncope

 9. Is pregnant or breastfeeding

 10. Previously enrolled in a clinical trial for etripamil and received study drug

 11. History of Acute Coronary Syndrome (ACS) or stroke within 6 months of screening

 12. 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 c) <35mL/min/1.73m2 for
 patients ≥70 years of age