Phase
Condition
Chest Pain
Dysrhythmia
Arrhythmia
Treatment
HBI-3000
Placebo
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 treatmentand for at least 30 days duration after treatment if indicated by ACC/AHA/HRS orcountry specific national or international guidelines for thromboembolic riskreduction related to AF
Exclusion
Exclusion Criteria:
Atrial fibrillation < 2 hours or > 72 hours duration or with duration not reliablyestablished at the time of dosing
Hemodynamic instability that may require emergency electrical cardioversion
Atrial flutter
Moderate to severe HF
Clinical or ECG signs of acute cardiac ischemia or digitalis toxicity
Known or suspected hyperthyroidism
Cardiac surgery, stroke, TIA, acute MI/ PCI, unstable angina, or persistent anginaat rest within the previous 3 months
Presence of LA thrombus by TEE or TTE
Presence of concurrent myocarditis or endocarditis
ECG abnormalities: Current QTcF > 480 msec; QRS interval > 120 msec and/or acomplete bundle branch block (BBB)l Delta wave or other pre-excitation patternconsistent with WPW syndrome; Acute coronary ischemia patterns
Use of medication that prolongs the QTc interval or history of: Long QT syndrome,congenital or acquired; Torsades de Pointes (TdP); Brugada Syndrome; Ventriculararrhythmia (not including infrequent isolated PVC)
Concurrent treatment with Class I or III antiarrhythmic drugs, metformin or strongCYP2D6 inhibitors (unless the medication is discontinued > 5 half-lives beforeenrollment)
Treatment with oral amiodarone in the previous 3 months or IV amiodaroneadministered 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 invasiveinvestigational medical device within 2 months prior to Study Drug administration,or current enrollment in another study with investigational agent or procedure
Clinically significant laboratory abnormalities
Study Design
Study Description
Connect with a study center
Gold Coast University Hospital
Southport, Queensland 4215
AustraliaSite Not Available
University Clinical Center of the Republic of Srpska
Banja Luka, 78000
Bosnia and HerzegovinaSite Not Available
Cardiology Department, PHI Hospital Sveti Vracevi
Bijeljina, 76300
Bosnia and HerzegovinaSite Not Available
University Clinical Center Tuzla
Tuzla, 75000
Bosnia and HerzegovinaSite Not Available
Centre hospitalier de L'Universite de Montral (CHUM)
Montréal, Quebec H2X 0C1
CanadaSite Not Available
Montreal Heart Institute
Montréal, Quebec H1T 1C8
CanadaSite Not Available
Centre integre de sante et de services sociaux de Lanaudiere - Hopital Pierre-Le Gardeur
Terrebonne, Quebec J6V 2H2
CanadaSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do 13620
Korea, Republic ofSite Not Available
Chonnam National University Hospital
Gwangju, 61707
Korea, Republic ofSite Not Available
Auckland City Hospital
Auckland, 1023
New ZealandSite Not Available
Waikato Hospital
Hamilton, 3240
New ZealandSite Not Available
Wellington Regional Hospital
Wellington, 6021
New ZealandSite Not Available
Niš University Clinical Center
Niš, Bulevar Doktora 18108
SerbiaSite Not Available
Clinical Hospital Center Zvezdara
Belgrade, 11120
SerbiaSite Not Available
Dedinje Institute for Cardiovascular Diseases
Belgrade, 11040
SerbiaSite Not Available
University Clinical Center of Serbia
Belgrade, 11000
SerbiaSite Not Available
University Hospital Medical Center Bezanijska kosa
Belgrade, 11080
SerbiaSite Not Available
Health Center Uzice
Užice, 31000
SerbiaSite Not Available
Grandview Medical Group Research
Birmingham, Alabama 35243
United StatesSite Not Available
HonorHealth Research Institute and Innovation
Scottsdale, Arizona 85258
United StatesSite Not Available
NCH Research Institute
Naples, Florida 34102
United StatesSite Not Available
Research Physicians Network Alliance/Florida Cardiology
Winter Park, Florida 32792
United StatesSite Not Available
Prairie Education & Research
Springfield, Illinois 62701
United StatesSite Not Available
St. Vincent Heart Center
Carmel, Indiana 46260
United StatesSite Not Available
Lutheran Hospital
Fort Wayne, Indiana 46804
United StatesSite Not Available
UofL Health - UofL Physicians, Cardiology Associates
Louisville, Kentucky 40202
United StatesSite Not Available
North Mississippi Medical Center
Tupelo, Mississippi 38801
United StatesSite Not Available
AMG Heart and Vascular Center
Bartlesville, Oklahoma 74006
United StatesSite Not Available
Ascension St. John Clinical Research Institute
Tulsa, Oklahoma 74101
United StatesSite Not Available
CHRISTUS Trinity Mother Frances Hospital - Tyler
Tyler, Texas 75701
United StatesSite Not Available
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