A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation
ConditionAtrial Fibrillation
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- BAY 3670549
- Placebo
Treatment groups
360 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov