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Clinical Trials in Poland / NCT07625215
Recruiting Phase 2

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

NCT07625215 · tracked via the Priya Life Science Poland tracker
Sponsor
Phase
Phase 2
Started
2026-08-18
Last updated
2026-09-09

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

BAY 3670549Placebo

BAY 3670549: intravenous (IV) treatment

Placebo: intravenous (IV) treatment

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Participant must be 18 to 85 years of age inclusive, at the time of signing the informed consent. * Participant is hemodynamically stable and does not require emergency cardioversion, as determined by the investigator. * Participant has a current episode of atrial fibrillation (AF) ongoing for at least 3 hours and no more than 30 days at the time of randomization. * Participant has an indication for electrical cardioversion of AF, as determined by the investigator according to standard clinical practice and national/institutional guidelines. * At randomization, successful initiation and achievement of therapeutic levels of anticoagulation therapy, as well as completion of imaging evaluation for left atrial thrombi, as appropriate for the duration of the AF episode and risk for the participant according to national guideline and institution-specific routine practice. * BMI within range \[18 - 39.9\] kg/m2. * Contraceptive use by participants or participant partners should be consistent with the study protocol and local regulations regarding the methods of contraception for those participating in clinical studies. * Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol * Willing and able to comply with the receipt, home use, and return of the continuous ECG recording device, as well as with the participation in scheduled telephone follow-up assessments. Exclusion Criteria: * Current atrial flutter (AFL) or combined AF/AFL * Contraindication for electrical cardioversion on planned treatment day * Documented severely dilated left atrium (left atrial diameter, LAD \>5 cm) measured by any modality within the 6 months prior to screening; if several values are available, the most recent one shall be reported. If left atrium diameter was not measured in the last 6 months or a major cardiovascular event occurred within the last 6 months, a new measurement must be done at screening * Unsuccessful conversion of current AF episode (pharmacologically or electrically) * Known severe valvular heart disease (e.g., severe mitral regurgitation, severe aortic stenosis) * Patients with NYHA Class ≥ III heart failure, or with active management of acute heart failure decompensation on treatment day. * History within the preceding 3 months prior to randomization of any of the following events, or any other significant cardiovascular event as judged by the investigator: * Stroke * Myocardial infarction * Unstable angina pectoris or other signs of myocardial ischemia * Cardiac surgery * Transcatheter valve replacement * Percutaneous coronary intervention (PCI) * Coronary artery bypass graft (CABG) or other revascularization procedure * Severe renal impairment, i.e., estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² (using CKD-EPI formula) or requiring dialysis * Severe hepatic impairment, i.e. Child Pugh Class C * Use of anti-arrhythmic class I or III drugs within 5 half-lives before study drug administration (oral amiodarone in the previous 3 months) * Hypertension with SBP ≥ 180 mmHg or hypotension (SBP \< 90 mmHg) at randomization (based on the second BP measurement) * Stressor-associated AF, i.e., in the setting of an acute and reversible stressor (e.g., cardiac surgery, myocarditis, endocarditis, sepsis, pneumonia, etc.). This includes ablation procedure within the preceding one month prior to randomization.

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
UCSF Advanced Heart Failure Comprehensive Care Center San Francisco California Withdrawn
UCHealth University of Colorado Hospital - Cardiology Aurora Colorado Not Yet Recruiting
Massachusetts General Hospital - Cardiology Boston Massachusetts Not Yet Recruiting
Henry Ford Hospital - Cardiology Detroit Michigan Not Yet Recruiting
Duke University Hospital - Cardiology Durham North Carolina Not Yet Recruiting
Texas Health Heart and Vascular Specialists - Fort Worth Fort Worth Texas Not Yet Recruiting
CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic Tyler Texas Withdrawn
UZ Leuven Gasthuisberg - Cardiology diseases department Leuven Flemish Brabant Not Yet Recruiting
Jessa Ziekenhuis | Hartcentrum Hasselt Hasselt Limburg Not Yet Recruiting
AZ Delta | Clinical Trial Center - Cardiology Roeselare West Flanders Not Yet Recruiting
University Multiprofile Hospital For Active Treatment Sveti Georgi' - EAD Department of Intensive Cardiology" Plovdiv Plovdiv Province Not Yet Recruiting
Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department Sofia Sofia City Province Not Yet Recruiting
University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Cardiology Clinic Sofia Sofia City Province Not Yet Recruiting
Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department Veliko Tarnovo Veliko Tarnovo Province Not Yet Recruiting
Medizinische Hochschule Hannover|Kardiologie und Angiologie Hanover Lower Saxony Not Yet Recruiting
Herz-und Diabeteszentrum NRW|Elektrophysiologie/Rhythmologie Bad Oeynhausen North Rhine-Westphalia Not Yet Recruiting
Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin Altenburg Thuringia Not Yet Recruiting
Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, Nefrológia Szekszárd Tolna County Not Yet Recruiting
Semmelweis Egyetem, Varosmajori Sziv- és Ergyogyaszati Klinika Budapest Hungary Not Yet Recruiting
Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC Acquaviva delle Fonti Italy Not Yet Recruiting
Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica Milan Italy Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari Roma Italy Not Yet Recruiting
Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia Torrette Italy Not Yet Recruiting
Maastricht UMC Maastricht Limburg Not Yet Recruiting
Universitair Medisch Centrum Groningen Groningen Netherlands Not Yet Recruiting
American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii Bielsko-Biala Poland Not Yet Recruiting
American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki Kardiologicznej Chrzanów Poland Not Yet Recruiting
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II Grodzisk Mazowiecki Poland Not Yet Recruiting
USK nr 4 w Lublinie - Kliniczny Odd. Kardiologii, Reh. Kardio., Ch. Wew. z Pododdzialem Intensywnej Opieki Kardio. Lublin Poland Not Yet Recruiting

More Bayer trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07625215 on ClinicalTrials.gov ↗ ← All trials in Poland