Testing Etripamil against a placebo for atrial fibrillation

Exclusion

• −Patients with a primary diagnosis of atrial flutter (typical or atypical) or atrial tachycardia. Patients with AF who have been observed to also experience atrial flutter within the same episode (i.e., "AFib/Flutter" or an admixture of AF and flutter within the same episode) are eligible.
• −History of heart failure (HF) New York Heart Association (NYHA) classification ≥Class III within the last 3 months.
• −The etiology of any HF should have been previously evaluated and addressed.
• −HF with a reduced ejection fraction and/or HF with a preserved ejection fraction are acceptable.
• −History of hemodynamic instability during AF, i.e., symptoms or signs of severe hypotension, or syncope due to a pause upon conversion from AF to sinus rhythm (SR).
• −History of unexplained syncope.
• −History of, or ECG evidence at the screening visitScreeningThe checks done before joining, to see whether a study fits.Read more →, of: sick sinus syndrome, Mobitz II second- or third-degree atrioventricular (AV) block bradycardia (\<40 bpm) or pauses \>3 seconds during waking hours, without a pacemaker.
• −History of, or ECG evidence at the Screening visit, of: torsades de pointes, ventricular fibrillation, or ventricular tachycardia, Brugada syndrome, an antegrade conducting accessory bypass tract (e.g., Wolff-Parkinson-White or Lown-Ganong-Levine syndromes), or long QT syndrome.
• −History of stroke, transient ischemic attack or peripheral embolism within the last 3 months.
• −CHA2DS2-VASc score of \>5.
• −Planned AF or AV node ablation within the next 3 months.
• −Uncorrected, severe aortic or mitral stenosis.
• −Hypertrophic cardiomyopathy with outflow tract obstruction.
• −History of sensitivity to verapamil or to any components of the investigational product.
• −History of recent or current chronic alcohol or drug abuse that, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, could impact the validity of the study results.
• −Currently participating in another drug or device study, or has received an investigational drug or device within 30 days prior to Screening.
• −Any other significant co-morbid condition that may negatively impact the patient's participation in the study or likely result in non-compliance.
• −History of any of the following within the last 6 months: Class 3 or 4 angina per Canadian Cardiovascular Society (CCS) criteria; ischemic chest pain during AF episodes; acute coronary syndrome, unless the patient has been successfully revascularized; coronary artery bypass grafting or open-chest valve surgery.