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NOT YET RECRUITING
NCT07625215
PHASE2

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

Sponsor: Bayer

View on ClinicalTrials.gov

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

Interventions

DRUG

BAY 3670549

intravenous (IV) treatment

OTHER

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