Atrial Fibrillation (AF)Phase 3BEAT-AFNCT06722196
BiodEgradable Soaked Amiodarone paTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery
A Phase 3 study testing topical amiodarone and saline solution patch in people with Atrial Fibrillation (AF), run by Jilin Heart Hospital at 1 site in China.
Trial summary
The primary objective of the present prospective, randomized, double blind, controlled study is to assess whether the application of 2 oxidized regenerated cellulose (SurgicelTM FibrillarTM) patches soaked with amiodarone hydrochloride over the anterior wall of the left atrium and the lateral wall of the right atrium… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- topical amiodarone and saline solution patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to 15 Dec 2027
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients who are candidates for elective cardiac surgery trough complete sternotomy with indications of coronary artery disease (both off-pump and on-pump), aortic valve disease, mitral valve disease, tricuspid valve disease, and ascending aorta disease, whether as an isolated pathology or in combination
Who cannot join
- patients with a clinical history of atrial or ventricular arrhythmia of any nature and duration, patients undergoing reoperation, patients with emergency surgical indications due to acute myocardial infarction or cardiogenic shock, patients with thyroid disfunction, patients with HOCM and those with pacemakers or ICDs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jilin Heart Hospital
Changchun, Jinlin, 130000
Xinlu MD, Medicine, 13630550989, xin.lu@jlheart.org
About this study
The primary objective of the present prospective, randomized, double blind, controlled study is to assess whether the application of 2 oxidized regenerated cellulose (SurgicelTM FibrillarTM) patches soaked with amiodarone hydrochloride over the anterior wall of the left atrium and the lateral wall of the right atrium results in a reduction in the incidence of POAF
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- topical amiodarone, saline solution patch
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical amiodaroneDrug
amiodarone soaked patch placed on the left atrial roof at the end of surgery
saline solution patchOther
saline solution soaked patch placed on left atrial roof at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | patients will receive 2 patches soaked in cordarone hydrochloride (150 mg/3 ml each) |
| Sham | Sham comparator | patients will receive 2 patches soaked in saline solution (3 ml each) |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative atrial fibrillation versus control
incidence of in-hospital atrial fibrillation
Measured: within 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start15 Feb 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University
- Responsible party
- Sponsor
- Investigators
- Massimo G Lemma, PhD, Principal investigator, Jilin Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722196
- Sponsor's protocol ID
- Jilin Heart Hospital 2024
- Acronym
- BEAT-AF
- Status last verified
- Feb 2025
- First submitted
- 5 Dec 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiodEgradable Soaked Amiodarone paTch Use for the Prevention of Atrial Fibrillation After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06722196
- Acronym / sponsor ID
- BEAT-AF / Jilin Heart Hospital 2024
- Conditions
- Atrial Fibrillation (AF)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Jilin Heart HospitalUniversity, hospital or other
- Collaborators
- Cornell University
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 9 Dec 2024 (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 primary objective of the present prospective, randomized, double blind, controlled study is to assess whether the application of 2 oxidized regenerated cellulose (SurgicelTM FibrillarTM) patches soaked with amiodarone hydrochloride over the anterior wall of the left atrium and the lateral wall of the right atrium results in a reduction in the incidence of POAF
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | –patients will receive 2 patches soaked in cordarone hydrochloride (150 mg/3 ml each) |
| Sham | Sham comparator | –patients will receive 2 patches soaked in saline solution (3 ml each) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who are candidates for elective cardiac surgery trough complete sternotomy with indications of coronary artery disease (both off-pump and on-pump), aortic valve disease, mitral valve disease, tricuspid valve disease, and ascending aorta disease, whether as an isolated pathology or in combination
Key exclusion criteria (1 listed)
- patients with a clinical history of atrial or ventricular arrhythmia of any nature and duration, patients undergoing reoperation, patients with emergency surgical indications due to acute myocardial infarction or cardiogenic shock, patients with thyroid disfunction, patients with HOCM and those with pacemakers or ICDs
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 |
|---|---|---|
| topical amiodaroneamiodarone soaked patch placed on the left atrial roof at the end of surgery | Drug | – |
| saline solution patchsaline solution soaked patch placed on left atrial roof at the end of surgery | Other | – |
Primary outcome
postoperative atrial fibrillation versus control
Time frame: within 5 days after surgery
incidence of in-hospital atrial fibrillation
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 9 Dec 2025.
- Individual participant dataSharing planned: No
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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.
Massimo G Lemma, PhD principal investigator
Jilin Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topical amiodarone and saline solution patch in people with Atrial Fibrillation (AF), run by Jilin Heart Hospital at 1 site in China.
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 1 inclusion and 1 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 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xin Lu (+86 13630550809, xin.lu@jlheart.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative atrial fibrillation versus control (time frame: within 5 days after surgery). 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 9 Dec 2025.