Principal Investigator: Benjamin Steinberg
Keywords: etripamil , tachycardia , nasal spray , cardiology Department: Cardiovascular Medicine
IRB Number: 00125954
Specialty: Cardiology
Sub Specialties: Cardiac Electrophysiology
Recruitment Status: Recruiting

Contact Information

Joe Goldstein

Brief Summary

1. The primary objective is to evaluate the safety of self-administered etripamil nasal spray (NS) outside of the clinical setting

Secondary Objectives:
1. To evaluate the efficacy of self-administered etripamil NS outside of the clinical setting, and
2. To evaluate the impact of etripamil NS on PSVT disease burden, and
3. To evaluate the safety and efficacy of etripamil NS when used for multiple PSVT episodes

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 SVT that includes the AV node as a critical part of reentrant circuit.  See Section 6.4 for details on diagnostic criteria.

*Patients to be enrolled in the study should generally experience symptomatic PSVT episodes which last more than 5 minutes. Patients with asymptomatic PSVT, or with short duration of episodes are unlikely to benefit from etripamil and should not be enrolled in the study.
Note that an actual tracing showing PSVT for longer than 5 minutes is not required for inclusion in the study.
* Suspected AV nodal dependency on an electrocardiographic recording is based on the following criteria: regular rhythm, heart rate above 100 bpm, narrow QRS complex, and possibly retrograde P waves.
* Patients who have had an ablation should have evidence (electrocardiographic and repeated clear symptoms) of PSVT occurring after the ablation in order to be enrolled in NODE-303.

2)   Is of 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

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 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:
a) <60mL/min/1.73m2 for patients <60 years of age
b) <40mL/min/1.73m2 for patients ≥60 and <70 years of age
c) <35mL/min/1.73m2 for patients ≥70 years of age