A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBayer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must be 18 to 85 years of age inclusive, at the time of signing the informed consent.
Participant is hemodynamically stable and does not require emergency cardioversion, as determined by the investigator.
Participant has a current episode of atrial fibrillation (AF) ongoing for at least 3 hours and no more than 30 days at the time of randomization.
Participant has an indication for electrical cardioversion of AF, as determined by the investigator according to standard clinical practice and national/institutional guidelines.
Disqualifiers
Current atrial flutter (AFL) or combined AF/AFL
Contraindication for electrical cardioversion on planned treatment day
Documented severely dilated left atrium (left atrial diameter, LAD >5 cm) measured by any modality within the 6 months prior to screening; if several values are available, the most recent one shall be reported. If left atrium diameter was not measured in the last 6 months or a major cardiovascular event occurred within the last 6 months, a new measurement must be done at screening
Unsuccessful conversion of current AF episode (pharmacologically or electrically)
Trial design
Design model
Parallel
Treatments tested in this trial
BAY 3670549
Drugintravenous (IV) treatment
Placebo
Other interventionintravenous (IV) treatment
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: BAY 3670549Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 interventionSecondary outcomes
1
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 intervention2
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 intervention3
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 intervention4
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 Source ClinicalTrials.gov