Last updated on December 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Paroxysmal Supraventricular Tachycardia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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:
  13. <60mL/min/1.73m2 for patients <60 years of age;
  14. <40mL/min/1.73m2 for patients 60 and <70 years of age c) <35mL/min/1.73m2 for patients 70 years of age

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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