pause_circle_filledNot Yet Recruiting
Atrial fibrillation
Bayer Identifier:
22961
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
2025-523807-31-00
A study to test how well BAY 3670549 works and how safe it is in patients with atrial fibrillation
Trial purpose
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.
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 Participants Requirements
Sex
AllAge
18 - 85 YearsTrial summary
Enrollment Goal
360Trial Dates
June 2026 - May 2030Phase
Phase IICould I Receive a placebo
YesProducts
BAY 3670549Accepts Healthy Volunteer
NoWhere to participate
| Status | Institution | Location |
|---|---|---|
Not Yet Recruiting | Medizinische Hochschule Hannover|Kardiologie und Angiologie | Hannover, 30625, Germany |
Not Yet Recruiting | Herz-und Diabeteszentrum NRW|Elektrophysiologie/Rhythmologie | Bad Oeynhausen, 32545, Germany |
Not Yet Recruiting | Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin | Altenburg, 04600, Germany |
Not Yet Recruiting | CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic | Tyler, 75701, United States |
Not Yet Recruiting | Massachusetts General Hospital - Cardiology | Boston, 02114, United States |
Not Yet Recruiting | Duke University Hospital - Cardiology | Durham, 27704, United States |
Not Yet Recruiting | UCSF Advanced Heart Failure Comprehensive Care Center | San Francisco, 94143, United States |
Not Yet Recruiting | UCHealth University of Colorado Hospital - Cardiology | Aurora, 80045, United States |
Not Yet Recruiting | Henry Ford Hospital - Cardiology | Detroit, 48202, United States |
Not Yet Recruiting | American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki Kardiologicznej | Chrzanow, 32-500, Poland |
Not Yet Recruiting | American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii | Bielsko-Biała, 43-316, Poland |
Not Yet Recruiting | USK nr 4 w Lublinie - Kliniczny Odd. Kardiologii, Reh. Kardio., Ch. Wew. z Pododdzialem Intensywnej Opieki Kardio. | Lublin, 20-090, Poland |
Not Yet Recruiting | Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II | Grodzisk Mazowiecki, 05 825, Poland |
Not Yet Recruiting | Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia | Torrette, 60126, Italy |
Not Yet Recruiting | Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica | Milano, 20138, Italy |
Not Yet Recruiting | Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari | Roma, 00161, Italy |
Not Yet Recruiting | Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC | Acquaviva delle Fonti, 70021, Italy |
Not Yet Recruiting | Jessa Ziekenhuis | Hartcentrum Hasselt | Hasselt, 3500, Belgium |
Not Yet Recruiting | UZ Leuven Gasthuisberg - Cardiology diseases department | Leuven, 3000, Belgium |
Not Yet Recruiting | AZ Delta | Clinical Trial Center - Cardiology | Roeselare, 8800, Belgium |
Not Yet Recruiting | Universitair Medisch Centrum Groningen | Groningen, 9713 GZ, Netherlands |
Not Yet Recruiting | Maastricht UMC | Maastricht, 6229 HX, Netherlands |
Not Yet Recruiting | Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department | Veliko Tarnovo, 5000, Bulgaria |
Not Yet Recruiting | Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department | Sofia, 1233, Bulgaria |
Not Yet Recruiting | University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Cardiology Clinic | Sofia, 1527, Bulgaria |
Not Yet Recruiting | University Multiprofile Hospital For Active Treatment Sveti Georgi' - EAD Department of Intensive Cardiology" | Plovdiv, 4001, Bulgaria |
Not Yet Recruiting | Semmelweis Egyetem, Varosmajori Sziv- és Ergyogyaszati Klinika | Budapest, 1122, Hungary |
Not Yet Recruiting | Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, Nefrológia | Szekszárd, 7100, Hungary |
Primary Outcome
- 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 cardioversionAF = atrial fibrillation ; SR = sinus rhythm ; SoC = Standard of Care ; *Pre-dose: Within 4 h prior to study intervention administrationdate_rangeTime Frame:From pre-dose* up to 3 hours after start of administration of study intervention
Secondary Outcome
- Number of Participants who experienced Treatment Emergent Adverse Events (TEAE)sTEAE = Treatment Emergent Adverse Events; *Pre-dose: Within 4 h prior to study intervention administrationdate_rangeTime Frame:From pre-dose* up to 48 h after start of administration of study intervention
- Time to conversion from AF to SR as defined in the primary endpointAF = atrial fibrillation SR = sinus rhythm ; *Pre-dose: Within 4 h prior to study intervention administrationdate_rangeTime Frame:From pre-dose* up to 3 hours after start of administration of study intervention
- Number of Participants in SR, at 3 hours after start of study intervention administration without prior use of rescue therapy or other SoC for cardioversionSoC = Standard of Care: *Pre-dose: Within 4 h prior to study intervention administrationdate_rangeTime Frame:From pre-dose* up to 3 hours after start of administration of study intervention
- Plasma concentration of BAY 3670549 at the end of the infusion*Pre-dose: Within 4 h prior to study intervention administrationdate_rangeTime Frame:From pre-dose* up to 8 h after start of administration of study intervention
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double-blindAssignment
ParallelTrial Arms
2