Atrial FibrillationSAFENCT07129564
Stepwise Strategy for Treatment of Atrialfibrillation Substrate Study
An observational study of Atrial Fibrillation, run by Yuehui Yin at 1 site in China.
Trial summary
Electrical/pharmacological cardioversion improves structural remodeling of left atrium. We hypothesized that radiofrequency ablation surgery for atrial fibrillation has a higher success rate and a lower recurrence rate of atrial fibrillation in patients with improved atrial stroma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- treatment react
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2023to 1 Jul 2026
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: persistent atrial fibrillation with left atrial enlargement
Who may be able to join
- Aged 18-80 years, with persistent atrial fibrillation complicated by left atrial enlargement (left atrial anteroposterior diameter 40-50mm); Having the willingness to undergo atrial fibrillation cardioversion and planned to receive amiodarone for pharmacological cardioversion; Having signed a written informed consent form for participation in the study; Not concurrently participating in any other interventional studies.
Who cannot join
- Females who are pregnant, lactating, or planning to have children within the next 2 years; Patients whose arrhythmia fails to convert to sinus rhythm with medication and who refuse electrical cardioversion; Patients whose arrhythmia cannot be converted to sinus rhythm with either medication or electrical cardioversion; Glomerular filtration rate (eGFR) < 30 ml/min/1.73m² (calculated by the CKD-EPI formula); Patients with biliary cirrhosis or cholestasis; Hyperthyroidism; A history of bradycardia (heart rate < 50 beats/min) or atrioventricular block of second degree or higher; Sick sinus syndrome; Known allergy to iodine, amiodarone, or any of its excipients; Concomitant use of other drugs that prolong the QT interval, or a history of torsades de pointes; Contraindications to atrial fibrillation cardioversion, such as cardiac thrombosis or contraindications to anticoagulation;
- A history or current presence of the following diseases or conditions:
- Moderate to severe rheumatic heart disease, valvular heart disease; a history of atrial-related surgery, including valve replacement, radiofrequency ablation for atrial fibrillation/atrial tachycardia/atrial flutter, atrial septal defect occlusion, or complex congenital heart disease surgery;
- A history of myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months;
- NYHA Class III-IV congestive heart failure or EF < 40%;
- Patients judged by the investigator to have poor compliance, inability to complete the study as required, or an expected lifespan of less than 1 year.
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
the second affiliated hospital of CQMU
Chongqing
About this study
Official title: Effects on Sinus Rhythm Maintenance and Atrial Remodeling After Cardioversion of Persistent Atrial Fibrillation: a Prospective, Multi-center, Cohort Study-stepwise Strategy for Treatment of Atrialfibrillation Substrate Study
Electrical/pharmacological cardioversion improves structural remodeling of left atrium. We hypothesized that radiofrequency ablation surgery for atrial fibrillation has a higher success rate and a lower recurrence rate of atrial fibrillation in patients with improved atrial stroma. This study is a multicenter, prospective, observational study conducted in China to evaluate whether sacubitril/valsartan can reduce atrial fibrillation recurrence rates, improve cardiac structure and function, and analyze the factors influencing the maintenance rate of sinus rhythm after atrial fibrillation ablation.
Read the detailed description
Background: Atrial fibrillation (AF) is associated with significant co-morbidities such as embolic stroke, heart failure, dementia. Consequently, AF poses a significant burden to the healthcare system, in both direct and indirect costs. The management of AF is complex, especially for patients with persistent AF. It is preferable to terminate the AF and restore normal sinus rhythm for relief of symptoms associated with AF or improvement of cardiac structure and function. The maintenance of AF, especially persist AF is associated with fibrosis of left atria. Furthermore, AF itself promotes fibrosis, which in turn leads to increased conduction heterogeneity within the atrial substrate resulting in further progression of AF. In animal models, alterations in myocytes after sustained AF resemble those of myocardial hibernation. Ultimately, these structural changes would lead to Calcium overload and metabolic stress, similar changes have been observed in humans. In humans, atrial dilatation and degenerative changes have been observed. Interstitial fibrosis is the prime cause of structural remodeling in left atrium. Whether reversal of sinus rhythm can reverse fibrosis partly? The introduction of Late Gadolinium enhancement magnetic resonance imaging (LGE-MRI) sequence now allows for non-invasive and dynamic assessment of the location and extent of atrial fibrosis.
The investigators propose to evaluate whether sacubitril/valsartan can reduce atrial fibrillation recurrence rates, improve cardiac structure and function, and analyze the factors influencing the maintenance rate of sinus rhythm after atrial fibrillation ablation.
Objectives:
Primary: In patients with persistent atrial fibrillation and left atrial enlargement, the first part: after drug or electrical cardioversion, on the basis of using amiodarone to maintain sinus rhythm, they were divided into the group prescribed sacubitril/valsartan and the control group, and evaluated whether sacubitril/valsartan could reduce the recurrence rate of atrial fibrillation, improve cardiac structure and function, and improve atrial fibrosis by comparing the maintenance rate of sinus rhythm after cardioversion, ultrasound assessment of atrial structure and function, cardiac MRI evaluation of cardiac structure, function and fibrosis.
The second part: Combined with the patient's wishes, researchers perform annular pulmonary vein isolation 3 to 6 months after cardioversion, evaluate the patient's sinus rhythm maintenance rate and cardiac structure and function at 3 months, 6 months, 1 year and 2 years after ablation. Then we will evaluate whether the improvement of atrial structure and function before surgery can predict the success rate of surgery, and evaluate whether sacubitril/valsartan further improves the success rate of surgery compared with the control group. If the number of patients in the subgroup is sufficient, subgroup analysis can be performed in a specific patient subgroup。
Secondary:
We will assess the effects on patients with the following outcomes, including: analysis of other factors influencing left atrial remodeling. The influencing factors will be analyze of sinus rhythm maintenance rate after other electrical cardioversion.If the number of patients in the subgroup is sufficient, subgroup analysis can be performed in a specific subgroup of patients
- Conditions
- Atrial Fibrillation
- Being tested
- treatment react
- Keywords
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment reactOther
Reverse remodeling of the LA was defined as at least a 15% reduction in the max LA volume after electrical or pharmacological cardioversion for 3 months
| Study group | Role | What they receive |
|---|---|---|
| reversed | at least a 15% reduction in the max LA volume Receives: Other: treatment react | |
| non-reversed | less than 15% reduction in the max LA volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of atrial tachyarrhythmia
the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start27 Apr 2023
- Primary completion25 Nov 2024
- Study completion1 Jul 2026 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuehui Yin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129564
- Sponsor's protocol ID
- SAFE study
- Acronym
- SAFE
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing such data without the patient's explicit authorization may violate their right to privacy and contravene the informed consent terms obtained in the study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Sinus Rhythm Maintenance and Atrial Remodeling After Cardioversion of Persistent Atrial Fibrillation: a Prospective, Multi-center, Cohort Study-stepwise Strategy for Treatment of Atrialfibrillation Substrate Study
- ClinicalTrials.gov ID
- NCT07129564
- Acronym / sponsor ID
- SAFE / SAFE study
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Yuehui YinUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 19 Aug 2025 (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.
Electrical/pharmacological cardioversion improves structural remodeling of left atrium. We hypothesized that radiofrequency ablation surgery for atrial fibrillation has a higher success rate and a lower recurrence rate of atrial fibrillation in patients with improved atrial stroma. This study is a multicenter, prospective, observational study conducted in China to evaluate whether sacubitril/valsartan can reduce atrial fibrillation recurrence rates, improve cardiac structure and function, and analyze the factors influencing the maintenance rate of sinus rhythm after atrial fibrillation ablation.
Detailed description
Background: Atrial fibrillation (AF) is associated with significant co-morbidities such as embolic stroke, heart failure, dementia. Consequently, AF poses a significant burden to the healthcare system, in both direct and indirect costs. The management of AF is complex, especially for patients with persistent AF. It is preferable to terminate the AF and restore normal sinus rhythm for relief of symptoms associated with AF or improvement of cardiac structure and function. The maintenance of AF, especially persist AF is associated with fibrosis of left atria. Furthermore, AF itself promotes fibrosis, which in turn leads to increased conduction heterogeneity within the atrial substrate resulting in further progression of AF. In animal models, alterations in myocytes after sustained AF resemble those of myocardial hibernation. Ultimately, these structural changes would lead to Calcium overload and metabolic stress, similar changes have been observed in humans. In humans, atrial dilatation and degenerative changes have been observed. Interstitial fibrosis is the prime cause of structural remodeling in left atrium. Whether reversal of sinus rhythm can reverse fibrosis partly? The introduction of Late Gadolinium enhancement magnetic resonance imaging (LGE-MRI) sequence now allows for non-invasive and dynamic assessment of the location and extent of atrial fibrosis.
The investigators propose to evaluate whether sacubitril/valsartan can reduce atrial fibrillation recurrence rates, improve cardiac structure and function, and analyze the factors influencing the maintenance rate of sinus rhythm after atrial fibrillation ablation.
Objectives:
Primary: In patients with persistent atrial fibrillation and left atrial enlargement, the first part: after drug or electrical cardioversion, on the basis of using amiodarone to maintain sinus rhythm, they were divided into the group prescribed sacubitril/valsartan and the control group, and evaluated whether sacubitril/valsartan could reduce the recurrence rate of atrial fibrillation, improve cardiac structure and function, and improve atrial fibrosis by comparing the maintenance rate of sinus rhythm after cardioversion, ultrasound assessment of atrial structure and function, cardiac MRI evaluation of cardiac structure, function and fibrosis.
The second part: Combined with the patient's wishes, researchers perform annular pulmonary vein isolation 3 to 6 months after cardioversion, evaluate the patient's sinus rhythm maintenance rate and cardiac structure and function at 3 months, 6 months, 1 year and 2 years after ablation. Then we will evaluate whether the improvement of atrial structure and function before surgery can predict the success rate of surgery, and evaluate whether sacubitril/valsartan further improves the success rate of surgery compared with the control group. If the number of patients in the subgroup is sufficient, subgroup analysis can be performed in a specific patient subgroup。
Secondary:
We will assess the effects on patients with the following outcomes, including: analysis of other factors influencing left atrial remodeling. The influencing factors will be analyze of sinus rhythm maintenance rate after other electrical cardioversion.If the number of patients in the subgroup is sufficient, subgroup analysis can be performed in a specific subgroup of patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reversed | – | Other: treatment reactat least a 15% reduction in the max LA volume |
| non-reversed | – | –less than 15% reduction in the max LA volume |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- persistent atrial fibrillation with left atrial enlargement
Key inclusion criteria (1 listed)
- Aged 18-80 years, with persistent atrial fibrillation complicated by left atrial enlargement (left atrial anteroposterior diameter 40-50mm); Having the willingness to undergo atrial fibrillation cardioversion and planned to receive amiodarone for pharmacological cardioversion; Having signed a written informed consent form for participation in the study; Not concurrently participating in any other interventional studies.
Key exclusion criteria (6 listed)
- Females who are pregnant, lactating, or planning to have children within the next 2 years; Patients whose arrhythmia fails to convert to sinus rhythm with medication and who refuse electrical cardioversion; Patients whose arrhythmia cannot be converted to sinus rhythm with either medication or electrical cardioversion; Glomerular filtration rate (eGFR) < 30 ml/min/1.73m² (calculated by the CKD-EPI formula); Patients with biliary cirrhosis or cholestasis; Hyperthyroidism; A history of bradycardia (heart rate < 50 beats/min) or atrioventricular block of second degree or higher; Sick sinus syndrome; Known allergy to iodine, amiodarone, or any of its excipients; Concomitant use of other drugs that prolong the QT interval, or a history of torsades de pointes; Contraindications to atrial fibrillation cardioversion, such as cardiac thrombosis or contraindications to anticoagulation;
- Moderate to severe rheumatic heart disease, valvular heart disease; a history of atrial-related surgery, including valve replacement, radiofrequency ablation for atrial fibrillation/atrial tachycardia/atrial flutter, atrial septal defect occlusion, or complex congenital heart disease surgery;
- A history of myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months;
- NYHA Class III-IV congestive heart failure or EF < 40%;
- Patients judged by the investigator to have poor compliance, inability to complete the study as required, or an expected lifespan of less than 1 year.
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 |
|---|---|---|
| treatment reactReverse remodeling of the LA was defined as at least a 15% reduction in the max LA volume after electrical or pharmacological cardioversion for 3 months | Other | reversed |
Primary outcome
recurrence of atrial tachyarrhythmia
Time frame: 1 year
the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug
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 19 Aug 2025.
- Individual participant dataSharing planned: No. Sharing such data without the patient's explicit authorization may violate their right to privacy and contravene the informed consent terms obtained in the study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Yuehui Yin 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 6 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 19 Aug 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Yuehui Yin (+8613508335502, yinyh63@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of atrial tachyarrhythmia (time frame: 1 year). 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 19 Aug 2025.