Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT04072835
Eligibility Criteria:
Inclusion Criteria:
A participant was eligible for study participation if they met all of the following criteria:
1. Had been diagnosed with PSVT by a medical professional, and reported having at least one previous episode of PSVT. For clarity, PSVT referred to episodic Supraventricular Tachycardia (SVT) that included the atrioventricular (AV) node as a critical part of reentrant circuit.
2. Was at least 18 years of age;
3. Signed NODE-303 written informed consent
4. Women of childbearing potential had to be willing to use at least 1 form of contraception during the trial, and had to be willing to discontinue from the study should they have become or planned to become pregnant. Postmenopausal females were 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 participant was excluded from the study if they met any of the following criteria:
1. Participants with only a history of atrial arrhythmia that did not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g. atrial fibrillation, atrial flutter, intra-atrial tachycardia) were not eligible. Participants with a history of these tachycardias who were also diagnosed with PSVT were eligible.
2. History of allergic reaction to verapamil
3. Current therapy with digoxin, or any Class I or III antiarrhythmic drug. Participants could be eligible if these drugs were stopped at least five half-lives before the administration of etripamil NS. The only exception was amiodarone which had to 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 participant, or impede the participant'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. Was 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 participants \<60 years of age;
2. \<40mL/min/1.73m2 for participants ≥60 and \<70 years of age
3. \<35mL/min/1.73m2 for participants ≥70 years of age
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04072835
Study Brief:
Protocol Section:
NCT04072835