Atrial Fibrillation study: BAY
Official title A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation
ClinicalTrials.gov ID: NCT07625215
What this study is testing
What is BAY 3670549?
An investigational intravenous medicine being studied for atrial fibrillation.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares BAY 3670549 to a placebo to determine how well it works, how safe it is, how well people tolerate it, and how the body processes the drug.
- Who it's for
- Adults with atrial fibrillation who need a procedure called electrical cardioversion.
- What's involved
- Participants receive a single IV infusion of either BAY 3670549 or a placebo and are monitored to see if their heart rhythm returns to normal. If it does not, the planned electrical cardioversion can still be performed.
- Time commitment
- The study lasts up to two months, with visits for the infusion, monitoring, and follow‑up assessments.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- At randomization, successful initiation and achievement of therapeutic levels of anticoagulation therapy, as well as completion of imaging evaluation...
You likely can't join if
- 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
- 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.
See the full eligibility 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...
- 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.
- 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.
- 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.
- 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.).
The study team makes the final eligibility decision.
Where it is enrolling
- Detroit, Michigan, United States
- Leuven, Flemish Brabant, Belgium
- Sofia, Sofia City Province, Bulgaria
- Veliko Tarnovo, Veliko Tarnovo Province, Bulgaria
- Altenburg, Thuringia, Germany
- Budapest, Hungary
- Acquaviva delle Fonti, Apulia, Italy
- Milan, Lombardy, Italy
- Grodzisk Mazowiecki, Masovian Voivodeship, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Detroit, Michigan, United States; Leuven, Flemish Brabant, Belgium; Sofia, Sofia City Province, Bulgaria; Veliko Tarnovo, Veliko Tarnovo Province, Bulgaria; Altenburg, Thuringia, Germany; Budapest, Hungary and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.