The main goal of this study is to find out how well BAY 3670549 works, how safe it is, how well people can tolerate it, and how the body handles the medicine. The study will compare BAY 3670549 to a placebo (a dummy treatment with no active medicine) in people with AF who need a treatment called electrical cardioversion. Electrical cardioversion is a procedure that helps the heart return to a normal rhythm. In this study, each participant will get a single intravenous (IV) infusion of either BAY 3670549 or a placebo. Participants will then be observed to see whether the heart rhythm returns to a normal rhythm. If it does not, electrical cardioversion can still be performed as planned. The study will look at how many participants return from AF to a normal rhythm, without needing electrical cardioversion and how long it takes. It will also show how many participants experience medical problems after treatment and how BAY 3670549 move into, through and out of the participants' body. The total duration of the study for an individual participant may be up two months. The findings from this study may contribute to the development of a new treatment option for people with AF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
360
intravenous (IV) treatment
intravenous (IV) treatment
UCSF Advanced Heart Failure Comprehensive Care Center
San Francisco, California, United States
WITHDRAWNUCHealth University of Colorado Hospital - Cardiology
Aurora, Colorado, United States
NOT_YET_RECRUITINGMassachusetts General Hospital - Cardiology
Boston, Massachusetts, United States
NOT_YET_RECRUITINGHenry Ford Hospital - Cardiology
Detroit, Michigan, United States
Number of Participants with conversion from atrial fibrillation (AF) to sinus rhythm (SR), sustained for ≥1 minute, within 3 hours after start of study intervention administration, and prior to use of rescue therapy or other SoC for cardioversion
AF = atrial fibrillation ; SR = sinus rhythm ; SoC = Standard of Care;
Time frame: Up to 3 hours after start of administration of study intervention
Number of Participants who experienced Treatment Emergent Adverse Events (TEAE)s
TEAE = Treatment Emergent Adverse Events; \*Pre-dose: Within 4 hours prior to study intervention administration
Time frame: From pre-dose* up to 48 hours after start of administration of study intervention
Time to conversion from AF to SR as defined in the primary endpoint
AF = atrial fibrillation SR = sinus rhythm;
Time frame: Up to 3 hours after start of administration of study intervention
Number of Participants in SR, at 3 hours after start of study intervention administration without prior use of rescue therapy or other SoC for cardioversion
SoC = Standard of Care;
Time frame: Up to 3 hours after start of administration of study intervention
Plasma concentration of BAY 3670549 at the end of the infusion
\*Pre-dose: Within 4 hours prior to study intervention administration
Time frame: From pre-dose* up to 8 hours after start of administration of study intervention
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Duke University Hospital - Cardiology
Durham, North Carolina, United States
NOT_YET_RECRUITINGTexas Health Heart and Vascular Specialists - Fort Worth
Fort Worth, Texas, United States
NOT_YET_RECRUITINGCHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic
Tyler, Texas, United States
WITHDRAWNUZ Leuven Gasthuisberg - Cardiology diseases department
Leuven, Flemish Brabant, Belgium
NOT_YET_RECRUITINGJessa Ziekenhuis | Hartcentrum Hasselt
Hasselt, Limburg, Belgium
NOT_YET_RECRUITINGAZ Delta | Clinical Trial Center - Cardiology
Roeselare, West Flanders, Belgium
NOT_YET_RECRUITING...and 19 more locations