Atrial FibrillationPhase 2CARDIOVERTNCT07625215
A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation
A Phase 2 study testing BAY 3670549 in people with Atrial Fibrillation, run by Bayer at 30 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- BAY 3670549
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 30 sitesin 8 countries
- Study dates
- 1 Sep 2026to 16 May 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
30 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
30 sites in 8 countries
United States8 sites, 6 recruiting
- Not yet recruiting
UCHealth University of Colorado Hospital - Cardiology
Aurora, Colorado, 80045
- Not yet recruiting
Massachusetts General Hospital - Cardiology
Boston, Massachusetts, 02114
- Recruiting
Henry Ford Hospital - Cardiology
Detroit, Michigan, 48202
- Not yet recruiting
Duke University Hospital - Cardiology
Durham, North Carolina, 27704
- Not yet recruiting
Texas Health Heart and Vascular Specialists - Fort Worth
Fort Worth, Texas, 76104
- Withdrawn
M Health Fairview Heart Clinic - Maplewood
Maplewood, Minnesota, 55109
- Withdrawn
UCSF Advanced Heart Failure Comprehensive Care Center
San Francisco, California, 94143
- Not yet recruiting
CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic
Tyler, Texas, 75701
Bulgaria4 sites, 4 recruiting
- Not yet recruiting
University Multiprofile Hospital For Active Treatment Sveti Georgi' - EAD Department of Intensive Cardiology"
Plovdiv, Plovdiv Province, 4001
- Not yet recruiting
Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department
Sofia, Sofia City Province, 1233
- Recruiting
University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Cardiology Clinic
Sofia, Sofia City Province, 1527
- Recruiting
Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department
Veliko Tarnovo, Veliko Tarnovo Province, 5000
Italy4 sites, 4 recruiting
- Recruiting
Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC
Acquaviva delle Fonti, Apulia, 70021
- Recruiting
Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica
Milan, Lombardy, 20138
- Not yet recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari
Rome, Lazio, 00161
- Not yet recruiting
Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia
Torrette, The Marches, 60126
Poland4 sites, 4 recruiting
- Not yet recruiting
American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii
Bielsko-Biala, Silesian Voivodeship, 43-316
- Not yet recruiting
American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki Kardiologicznej
Chrzanów, Lesser Poland Voivodeship, 32-500
- Recruiting
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II
Grodzisk Mazowiecki, Masovian Voivodeship, 05-825
- Not yet recruiting
USK nr 4 w Lublinie - Kliniczny Odd. Kardiologii, Reh. Kardio., Ch. Wew. z Pododdzialem Intensywnej Opieki Kardio.
Lublin, Lublin Voivodeship, 20-090
Belgium3 sites, 3 recruiting
- Not yet recruiting
Jessa Ziekenhuis | Hartcentrum Hasselt
Hasselt, Limburg, 3500
- Recruiting
UZ Leuven Gasthuisberg - Cardiology diseases department
Leuven, Flemish Brabant, 3000
- Not yet recruiting
AZ Delta | Clinical Trial Center - Cardiology
Roeselare, West Flanders, 8800
Germany3 sites, 3 recruiting
- Recruiting
Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin
Altenburg, Thuringia, 04600
- Not yet recruiting
Herz-und Diabeteszentrum NRW|Elektrophysiologie/Rhythmologie
Bad Oeynhausen, North Rhine-Westphalia, 32545
- Not yet recruiting
Medizinische Hochschule Hannover|Kardiologie und Angiologie
Hanover, Lower Saxony, 30625
Hungary2 sites, 2 recruiting
- Recruiting
Semmelweis Egyetem, Varosmajori Sziv- és Ergyogyaszati Klinika
Budapest, 1122
- Not yet recruiting
Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, Nefrológia
Szekszárd, Tolna County, 7100
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
- Not yet recruiting
Maastricht UMC
Maastricht, Limburg, 6229 HX
About this study
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.
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.
Read more
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.
- Conditions
- Atrial Fibrillation
- Being tested
- BAY 3670549, Placebo
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY 3670549Drug
intravenous (IV) treatment
PlaceboOther
intravenous (IV) treatment
| Study group | Role | What they receive |
|---|---|---|
| BAY 3670549 | Experimental | Not described Receives: Drug: BAY 3670549 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
AF = atrial fibrillation ; SR = sinus rhythm ; SoC = Standard of Care;
Measured: Up to 3 hours after start of administration of study intervention
Secondary outcomes (4)
Number of Participants who experienced Treatment Emergent Adverse Events (TEAE)s
TEAE = Treatment Emergent Adverse Events; *Pre-dose: Within 4 hours prior to study intervention administration
Measured: From pre-dose* up to 48 hours after start of administration of study intervention
Time to conversion from AF to SR as defined in the primary endpoint
AF = atrial fibrillation SR = sinus rhythm;
Measured: 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 cardioversion
SoC = Standard of Care;
Measured: 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 hours prior to study intervention administration
Measured: From pre-dose* up to 8 hours after start of administration of study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Sep 2026
- Primary completion16 May 2030 (estimated)
- Study completion16 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625215
- Sponsor's protocol ID
- 22961
- Other IDs
- 2025-523807-31-00, 2025
- Acronym
- CARDIOVERT
- Status last verified
- 6 Oct 2026
- First submitted
- 13 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07625215
- Acronym / sponsor ID
- CARDIOVERT / 22961
- Conditions
- Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 16 May 2030 (estimated)
- Study completion
- 16 May 2030 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY 3670549 | Experimental | Drug: BAY 3670549 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY 3670549intravenous (IV) treatment | Drug | BAY 3670549 |
| Placebointravenous (IV) treatment | Other | Placebo |
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 cardioversion
Time frame: Up to 3 hours after start of administration of study intervention
AF = atrial fibrillation ; SR = sinus rhythm ; SoC = Standard of Care;
4 secondary outcomes
Number of Participants who experienced Treatment Emergent Adverse Events (TEAE)s
Time frame: From pre-dose* up to 48 hours after start of administration of study intervention
Time to conversion from AF to SR as defined in the primary endpoint
Time frame: 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 cardioversion
Time frame: Up to 3 hours after start of administration of study intervention
Plasma concentration of BAY 3670549 at the end of the infusion
Time frame: From pre-dose* up to 8 hours after start of administration of study intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAY 3670549 in people with Atrial Fibrillation, run by Bayer at 30 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Bulgaria, Italy, Poland, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact (18888422937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.