360 Participants NeededMy employer runs this trial

BAY 3670549 for Atrial Fibrillation

(CARDIOVERT Trial)

Recruiting at 26 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Bayer
Must be taking: Anticoagulation therapy
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults with atrial fibrillation (AF) who are scheduled to have an electrical cardioversion procedure. Participants should be able to receive an IV infusion and follow study instructions. People with certain health conditions or risks may not be eligible.

Inclusion Criteria

Participant is hemodynamically stable and does not require emergency cardioversion as determined by the investigator
I am between 18 and 85 years old.
I have had atrial fibrillation for at least 3 hours but less than 30 days.
See 6 more

Exclusion Criteria

I have severe liver impairment (Child Pugh Class C).
I cannot safely undergo electrical cardioversion on the treatment day.
I have severe kidney problems or need dialysis.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single intravenous (IV) infusion of either BAY 3670549 or a placebo

1 day
1 visit (in-person)

Observation

Participants are observed for conversion from atrial fibrillation to sinus rhythm and monitored for adverse events

48 hours
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 months

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests a single IV dose of BAY 3670549 versus a placebo in people with AF before planned electrical cardioversion. It aims to see if the drug can restore normal heart rhythm without needing the procedure, and monitors safety over about two months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: BAY 3670549Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials
2,291
Recruited
25,560,000+
Founded
1863
Headquarters
Leverkusen, Germany
Known For
Pharmaceutical Innovations
Top Products
Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD