A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)

Korábbi kezelés

• Cardiac surgery, stroke, TIA, acute MI/ PCI, unstable angina, or persistent angina at rest within the previous 3 months
• Presence of concurrent myocarditis or endocarditis
• Concurrent treatment with Class I or III antiarrhythmic drugs, metformin or strong CYP2D6 inhibitors (unless the medication is discontinued > 5 half-lives before enrollment)
• Treatment with oral amiodarone in the previous 3 months or IV amiodarone administered within 24 hours prior to planned Study Drug administration
• Use of vernakalant, or any experimental drug within 30 days or five half-lives (whichever is longer) of Study Drug administration, or use of an invasive investigational medical device within 2 months prior to Study Drug administration, or current enrollment in another study with investigational agent or procedure

Más betegség

• Clinical or ECG signs of acute cardiac ischemia or digitalis toxicity
• ECG abnormalities: Current QTcF > 480 msec; QRS interval > 120 msec and/or a complete bundle branch block (BBB)l Delta wave or other pre-excitation pattern consistent with WPW syndrome; Acute coronary ischemia patterns

Laborértékek

• Use of medication that prolongs the QTc interval or history of: Long QT syndrome, congenital or acquired; Torsades de Pointes (TdP); Brugada Syndrome; Ventricular arrhythmia (not including infrequent isolated PVC)
• Clinically significant laboratory abnormalities

Egyéb

• Atrial fibrillation < 2 hours or > 72 hours duration or with duration not reliably established at the time of dosing
• Hemodynamic instability that may require emergency electrical cardioversion
• Atrial flutter
• Moderate to severe HF
• Known or suspected hyperthyroidism
• Presence of LA thrombus by TEE or TTE

• 18 to 80 years of age
• Sustained AF of > 2 hours and < 72 hours duration
• Eligible for cardioversion (electrical and pharmacologic)
• On adequate anticoagulant therapy or eligible for anticoagulation during treatment and for at least 30 days duration after treatment if indicated by ACC/AHA/HRS or country specific national or international guidelines for thromboembolic risk reduction related to AF