A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation

Part of paid clinical trials in San Francisco, California.

Sponsor
Bayer
Study ID
NCT07625215
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • BAY 3670549 — DRUG
    intravenous (IV) treatment
  • Placebo — OTHER
    intravenous (IV) treatment

Study Details

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.

Key Dates

Start date
Jun 19, 2026
Status verified
Feb 2026
Primary completion
May 16, 2030
Completion
May 16, 2030

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BAY 3670549
  • Placebo Comparator: Placebo

Primary Outcome Measure

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 [ Time Frame: Up to 3 hours after start of administration of study intervention ]

Central Contacts

Locations (6)

FacilityCityStateZIP
UCSF Advanced Heart Failure Comprehensive Care CenterSan FranciscoCalifornia94143
UCHealth University of Colorado Hospital - CardiologyAuroraColorado80045
Massachusetts General Hospital - CardiologyBostonMassachusetts02114
Henry Ford Hospital - CardiologyDetroitMichigan48202
Duke University Hospital - CardiologyDurhamNorth Carolina27704
CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology ClinicTylerTexas75701

Find similar trials in San Francisco, CA

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
UCSF Advanced Heart Failure Comprehensive Care Center· San Francisco, CAUCHealth University of Colorado Hospital - Cardiology· Aurora, COMassachusetts General Hospital - Cardiology· Boston, MAHenry Ford Hospital - Cardiology· Detroit, MIDuke University Hospital - Cardiology· Durham, NCCHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic· Tyler, TX

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