Recruiting
Phase 2

BAY 3670549

Sponsor:

Bayer

Code:

NCT07625215

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BAY 3670549

Placebo

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Study ID

NCT07625215

Start date

Sep 1, 2026

Status verified date

Oct 6, 2026

Completion date

May 16, 2030

Anticipated

Primary completion date

May 16, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BAY 3670549

placebo comparator: Placebo

Interventions

BAY 3670549

intravenous (IV) treatment

Placebo

intravenous (IV) treatment

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 ]

Central Contacts and Locations

Central contacts

Bayer Clinical Trials Contact

18888422937clinical-trials-contact@bayer.com

Locations

Henry Ford Hospital - Cardiology

Recruiting

Detroit, Michigan, United States, 48202

More Information

Sponsor

Bayer

Last update posted

Oct 20, 2026

Last verified

Oct 6, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Bayer on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.