• June 17, 2019

    Enrollment opens in Temple and Round Rock for Phase III PSVT trial conducted in an outpatient setting

Baylor Scott & White Medical Centers in Temple and Round Rock have opened enrollment on a study examining the safety and efficacy of Etripamil Nasal Spray in terminating paroxysmal supraventricular tachycardia (PSVT). These locations represent two of just four sites across the entire state of Texas that were awarded the trial.

NODE-301: Multi-Centre, randomized, double-blind, placebo-controlled, efficacy and safety study of Etripamil Nasal Spray for the termination of spontaneous episodes of paroxysmal supraventricular tachycardia

The study is designed to help assess three aspects of the drug’s use. The primary objective is to determine if the drug is superior to placebo as a PSVT treatment by terminating PSVT episodes when self-administered by patients. Secondary and observational objectives include determining safety in self-administration without medical supervision, and the general safety, hemodynamic and cardiac conduction effects of a test dose of Etripamil NS 70 mg.

Inclusion Criteria:

  1. Male or female patients at least 18 years of age
  2. Electrographically documented history of PSVT (e.g., ECG obtained during an episode of PSVT, Holter monitoring, or loop recorder, etc.)
  3. History of sustained episodes of PSVT (i.e., typically lasting approximately 20 minutes or longer)
  4. Signed written informed consent

Exclusion Criteria:

  1. History of severe symptoms of hypotension, especially syncope, during episodes of PSVT
  2. History of atrial arrhythmia that does not involve the AV node as part of the tachycardia circuit (e.g., atrial fibrillation, atrial flutter, intra-atrial tachycardia)
  3. History of allergic reaction to verapamil
  4. Current therapy with digoxin or any Class I or III antiarrhythmic drug, except if these drugs are stopped at least the equivalent of 5 half-lives before the Test Dose Randomization Visit

Complete inclusion and exclusion criteria can be found here.

Baylor Scott & White Medical Center – Temple

Principal Investigator: James Black, MD
Study Contact: Wanda Fikes, 254.724.5373

Baylor Scott & White Medical Center – Round Rock

Principal Investigator: Javier Banchs, MD
Study Contact: Laura Carter, 512.218.6378