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A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation
Sponsor: Bayer
Summary
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.
Official title: A Placebo-controlled, Parallel-group, Double Blind, Randomized, Multi-cohort Phase 2 Study to Investigate Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BAY 3670549 in Adult Participants With Atrial Fibrillation.
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-07-17
Completion Date
2030-05-16
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
BAY 3670549
intravenous (IV) treatment
Placebo
intravenous (IV) treatment
Locations (28)
UCSF Advanced Heart Failure Comprehensive Care Center
San Francisco, California, United States
UCHealth University of Colorado Hospital - Cardiology
Aurora, Colorado, United States
Massachusetts General Hospital - Cardiology
Boston, Massachusetts, United States
Henry Ford Hospital - Cardiology
Detroit, Michigan, United States
Duke University Hospital - Cardiology
Durham, North Carolina, United States
CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic
Tyler, Texas, United States
UZ Leuven Gasthuisberg - Cardiology diseases department
Leuven, Flemish Brabant, Belgium
Jessa Ziekenhuis | Hartcentrum Hasselt
Hasselt, Limburg, Belgium
AZ Delta | Clinical Trial Center - Cardiology
Roeselare, West Flanders, Belgium
University Multiprofile Hospital For Active Treatment Sveti Georgi' - EAD Department of Intensive Cardiology"
Plovdiv, Plovdiv Province, Bulgaria
Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department
Sofia, Sofia City Province, Bulgaria
University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Cardiology Clinic
Sofia, Sofia City Province, Bulgaria
Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department
Veliko Tarnovo, Veliko Tarnovo Province, Bulgaria
Medizinische Hochschule Hannover|Kardiologie und Angiologie
Hanover, Lower Saxony, Germany
Herz-und Diabeteszentrum NRW|Elektrophysiologie/Rhythmologie
Bad Oeynhausen, North Rhine-Westphalia, Germany
Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin
Altenburg, Thuringia, Germany
Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, Nefrológia
Szekszárd, Tolna County, Hungary
Semmelweis Egyetem, Varosmajori Sziv- és Ergyogyaszati Klinika
Budapest, Hungary
Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC
Acquaviva delle Fonti, Italy
Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica
Milan, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari
Roma, Italy
Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia
Torrette, Italy
Maastricht UMC
Maastricht, Limburg, Netherlands
Universitair Medisch Centrum Groningen
Groningen, Netherlands
American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii
Bielsko-Biala, Poland
American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki Kardiologicznej
Chrzanów, Poland
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II
Grodzisk Mazowiecki, Poland
USK nr 4 w Lublinie - Kliniczny Odd. Kardiologii, Reh. Kardio., Ch. Wew. z Pododdzialem Intensywnej Opieki Kardio.
Lublin, Poland