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New drug aims to shock heart back to rhythm without electricity

NCT ID NCT07625215

Symptom relief Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 6 times

Summary

This study tests an experimental medicine called BAY 3670549 in 360 adults with atrial fibrillation (an irregular heartbeat). Participants receive a single IV dose of the drug or a placebo to see if it can restore normal heart rhythm without needing an electrical shock procedure. The study also checks for side effects and how the body processes the medicine.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Delta | Clinical Trial Center - Cardiology

    NOT_YET_RECRUITING

    Roeselare, West Flanders, 8800, Belgium

  • American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki Kardiologicznej

    NOT_YET_RECRUITING

    Chrzanów, 32-500, Poland

  • American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii

    NOT_YET_RECRUITING

    Bielsko-Biala, 43-316, Poland

  • Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia

    NOT_YET_RECRUITING

    Torrette, 60126, Italy

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari

    NOT_YET_RECRUITING

    Roma, 00161, Italy

  • CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic

    WITHDRAWN

    Tyler, Texas, 75701, United States

  • Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica

    RECRUITING

    Milan, 20138, Italy

  • Duke University Hospital - Cardiology

    NOT_YET_RECRUITING

    Durham, North Carolina, 27704, United States

  • Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC

    NOT_YET_RECRUITING

    Acquaviva delle Fonti, 70021, Italy

  • Henry Ford Hospital - Cardiology

    NOT_YET_RECRUITING

    Detroit, Michigan, 48202, United States

  • Herz-und Diabeteszentrum NRW|Elektrophysiologie/Rhythmologie

    NOT_YET_RECRUITING

    Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

  • Jessa Ziekenhuis | Hartcentrum Hasselt

    NOT_YET_RECRUITING

    Hasselt, Limburg, 3500, Belgium

  • Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin

    NOT_YET_RECRUITING

    Altenburg, Thuringia, 04600, Germany

  • Maastricht UMC

    NOT_YET_RECRUITING

    Maastricht, Limburg, 6229 HX, Netherlands

  • Massachusetts General Hospital - Cardiology

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medizinische Hochschule Hannover|Kardiologie und Angiologie

    NOT_YET_RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department

    NOT_YET_RECRUITING

    Veliko Tarnovo, Veliko Tarnovo Province, 5000, Bulgaria

  • Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department

    NOT_YET_RECRUITING

    Sofia, Sofia City Province, 1233, Bulgaria

  • Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II

    NOT_YET_RECRUITING

    Grodzisk Mazowiecki, 05-825, Poland

  • Semmelweis Egyetem, Varosmajori Sziv- és Ergyogyaszati Klinika

    NOT_YET_RECRUITING

    Budapest, 1122, Hungary

  • Texas Health Heart and Vascular Specialists - Fort Worth

    NOT_YET_RECRUITING

    Fort Worth, Texas, 76104, United States

  • Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, Nefrológia

    NOT_YET_RECRUITING

    Szekszárd, Tolna County, 7100, Hungary

  • UCHealth University of Colorado Hospital - Cardiology

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • UCSF Advanced Heart Failure Comprehensive Care Center

    WITHDRAWN

    San Francisco, California, 94143, United States

  • USK nr 4 w Lublinie - Kliniczny Odd. Kardiologii, Reh. Kardio., Ch. Wew. z Pododdzialem Intensywnej Opieki Kardio.

    NOT_YET_RECRUITING

    Lublin, 20-090, Poland

  • UZ Leuven Gasthuisberg - Cardiology diseases department

    NOT_YET_RECRUITING

    Leuven, Flemish Brabant, 3000, Belgium

  • Universitair Medisch Centrum Groningen

    NOT_YET_RECRUITING

    Groningen, 9713 GZ, Netherlands

  • University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Cardiology Clinic

    NOT_YET_RECRUITING

    Sofia, Sofia City Province, 1527, Bulgaria

  • University Multiprofile Hospital For Active Treatment Sveti Georgi' - EAD Department of Intensive Cardiology"

    NOT_YET_RECRUITING

    Plovdiv, Plovdiv Province, 4001, Bulgaria

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