Study to Investigate the Safety of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1116

Inclusion 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.
2) Is of at least 18 years of age
3) Signed NODE-303 written informed consent
4) Women of child-bearing potential who are sexually active must be willing to use at least 1 form of contraception from the time of signed informed consent until 7 days after the last administration of study drug, and must be willing to discontinue from the study should they become or plan to become pregnant
Approved forms of contraception include hormonal intrauterine devices or hormonal contraceptives (oral birth control pills, DepoProvera, patch, or other injectables) or single barrier methods such as condoms or diaphragms with spermicidal gel or foam;
The following categories define females who are NOT considered to be of childbearing potential:
Premenopausal females with 1 of the following:
a) Documented hysterectomy;
b) Documented bilateral salpingectomy; or
c) Documented bilateral oophorectomy; or
d) Postmenopausal females, defined as having amenorrhea for at least 12 months without an alternative medical cause.
All females who do not meet the above criteria are considered to be of childbearing potential.
5) Willing and able to comply with study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1950
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1050

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
13) SBP<90 mmHg
14) Has known allergies to adhesive materials or hydrogel used in the Cardiac Monitoring Device

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 12/13/2021

Study to Investigate the Safety of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia

Recruitment & Eligibility

Study & Design

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