Atrial FibrillationSAFE-extendedNCT07380620
Stepwise Strategy for Treatment of Atrial Fibrillation Substrate Extended Study
An observational study of Atrial Fibrillation, run by Yuehui Yin at 1 site in China.
Trial summary
This is an observational, bidirectional cohort study, aiming to establish a long-term registry of adult patients with Persistent atrial fibrillation (ps-AF) in Southwest China to characterize patient profiles and evaluate embolism risk, rate control, rhythm control and complication management and outcomes over 5… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- other
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to 31 Dec 2035
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: persistent atrial fibrillation
Who may be able to join
- Aged ≥18 years;
- diagnosed with persistent atrial fibrillation (ps-AF), defined as episodes lasting >7 days or requiring pharmacological/electrical cardioversion for rhythm restoration;
- Residing in Southwest China and capable of cooperating with long-term follow-up management;
- History of ps-AF treatment with complete medical records, and voluntary signing of the informed consent for long-term follow-up.
Who cannot join
- Comorbid severe hepatic/renal dysfunction or malignant tumors;
- Estimated survival period <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.
About this study
Official title: Persistent Atrial Fibrillation in Southwest China Cohort Study-Stepwise Strategy for Treatment of Atrial Fibrillation Substrate Extended Study
This is an observational, bidirectional cohort study, aiming to establish a long-term registry of adult patients with Persistent atrial fibrillation (ps-AF) in Southwest China to characterize patient profiles and evaluate embolism risk, rate control, rhythm control and complication management and outcomes over 5 years' follow-up. The objectives of the study are to: Describe the demographic, clinical, and treatment characteristics of ps-AF patients across Southwest China and assess the effectiveness and safety of various AF treatment strategies, including oral anticoagulation, electrical cardioversion, catheter ablation, and left atrial appendage closure, in routine clinical practice. Identify patient- and treatment-related factors that influence therapeutic outcomes. Explore the characteristics of imaging multi-omics and blood multi-omics during follow-up. Explore the role of advanced technologies and artificial intelligence in improving procedural performance, risk stratification, and clinical decision-making in AF care. Participants will undergo standardized baseline evaluation and longitudinal follow-up to collect data on heart rhythm monitoring, treatment exposures, healthcare utilization, clinical events, and patient-reported outcomes. This cohort will generate real-world evidence to inform personalized and evidence-based management of AF.
Read the detailed description
Background: Atrial fibrillation (AF) is estimated to affect over 33 million people worldwide and is associated with significant comorbidity such as embolism stroke, heart failure, dementia, etc. 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, which is defined as sustained AF for > 7 days. 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 humans, atrial dilatation and degenerative changes have been observed. Persistent atrial fibrillation (AF) is a sustained form of AF associated with higher risks of stroke, heart failure, and mortality compared to paroxysmal AF. Managing persistent AF is challenging due to its complex mechanisms, lower success rates with standard treatments, and greater likelihood of recurrence. Research focuses on understanding its progression, identifying risk factors, and optimizing treatment strategies. Patients with persistent AF at diagnosis may differ in age, heart failure prevalence, and ejection fraction, but the pattern at diagnosis does not significantly affect ablation outcomes or AF recurrence rates.
Objectives: Describe the demographic, clinical, and treatment characteristics of ps-AF patients across Southwest China and assess the effectiveness and safety of various AF treatment strategies, including oral anticoagulation, electrical cardioversion, catheter ablation, and left atrial appendage closure, in routine clinical practice. Identify patient- and treatment-related factors that influence therapeutic outcomes. Explore the prevalence and treatment strategies of bradyarrhythmia in ps-AF patients. Explore the characteristics of imaging multi-omics and blood multi-omics during follow-up. Explore the role of advanced technologies and artificial intelligence in improving procedural performance, risk stratification, and clinical decision-making in AF care. Participants will undergo standardized baseline evaluation and longitudinal follow-up (prospective and retrospective) to collect data on heart rhythm monitoring, treatment exposures, healthcare utilization, clinical events, and patient-reported outcomes. This cohort will generate real-world evidence to inform personalized and evidence-based management of AF.
- Conditions
- Atrial Fibrillation
- Being tested
- other
- 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.
otherOther
This study mainly describe the evolution and characteristic of patients with atrial fibrillation under different treatment plans and comorbidities.
| Study group | Role | What they receive |
|---|---|---|
| normal LA group | the patients in this group have a normal size of left atrium. | |
| enlarged LA group | the patients in this group have an enlarged size of left atrium. Receives: Other: other | |
| with HF group | the patients in this group suffer from heart failure. Receives: Other: other | |
| without HF group | the patients in this group don't suffer from heart failure. | |
| HR control group | the patients in this group accept the therapy focus on heart rate control. | |
| Rhythm control group | the patients in this group accept the therapy focus on rhythm control. Receives: Other: other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of stroke, major bleeding, worsening and new-onset heart failure, all-cause mortality
Composite endpoint of stroke, major bleeding, worsening heart failure, new-onset heart failure, and all-cause mortality
Measured: 5 years
Major bleeding events, perioperative complications and adverse drug reactions
Major bleeding events (e.g., intracranial hemorrhage, gastrointestinal bleeding); Perioperative complications (e.g., pericardial tamponade, thrombus formation, vascular complications); Adverse drug reactions (e.g., anticoagulant-induced thrombocytopenia, amiodarone-induced thyroid dysfunction, prolonged QT interval, bradyarrhythmia, pulmonary fibrosis, etc.).
Measured: 5 years
Secondary outcomes (1)
Incidence of MACCE, SSS, AF recurrence and embolism events
Incidence of MACCE (Major Adverse Cardiovascular and Cerebrovascular Events); Sinus rhythm maintenance rate, AF recurrence time, duration of persistent recurrence (assessed via 12-lead ECG + Holter, defined as atrial arrhythmia lasting ≥30 seconds); Incidence of stroke or systemic embolism events.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start9 Oct 2025
- Primary completion9 Oct 2035 (estimated)
- Study completion31 Dec 2035 (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
- 5,000 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
- NCT07380620
- Sponsor's protocol ID
- SAFE-extended study
- Acronym
- SAFE-extended
- Status last verified
- Jan 2026
- First submitted
- 28 Sep 2025
- Last updated
- 2 Feb 2026
- 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 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Atrial Fibrillation in Southwest China Cohort Study-Stepwise Strategy for Treatment of Atrial Fibrillation Substrate Extended Study
- ClinicalTrials.gov ID
- NCT07380620
- Acronym / sponsor ID
- SAFE-extended / SAFE-extended study
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Yuehui YinUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 9 Oct 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 2 Feb 2026 (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.
This is an observational, bidirectional cohort study, aiming to establish a long-term registry of adult patients with Persistent atrial fibrillation (ps-AF) in Southwest China to characterize patient profiles and evaluate embolism risk, rate control, rhythm control and complication management and outcomes over 5 years' follow-up. The objectives of the study are to: Describe the demographic, clinical, and treatment characteristics of ps-AF patients across Southwest China and assess the effectiveness and safety of various AF treatment strategies, including oral anticoagulation, electrical cardioversion, catheter ablation, and left atrial appendage closure, in routine clinical practice. Identify patient- and treatment-related factors that influence therapeutic outcomes. Explore the characteristics of imaging multi-omics and blood multi-omics during follow-up. Explore the role of advanced technologies and artificial intelligence in improving procedural performance, risk stratification, and clinical decision-making in AF care. Participants will undergo standardized baseline evaluation and longitudinal follow-up to collect data on heart rhythm monitoring, treatment exposures, healthcare utilization, clinical events, and patient-reported outcomes. This cohort will generate real-world evidence to inform personalized and evidence-based management of AF.
Detailed description
Background: Atrial fibrillation (AF) is estimated to affect over 33 million people worldwide and is associated with significant comorbidity such as embolism stroke, heart failure, dementia, etc. 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, which is defined as sustained AF for > 7 days. 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 humans, atrial dilatation and degenerative changes have been observed. Persistent atrial fibrillation (AF) is a sustained form of AF associated with higher risks of stroke, heart failure, and mortality compared to paroxysmal AF. Managing persistent AF is challenging due to its complex mechanisms, lower success rates with standard treatments, and greater likelihood of recurrence. Research focuses on understanding its progression, identifying risk factors, and optimizing treatment strategies. Patients with persistent AF at diagnosis may differ in age, heart failure prevalence, and ejection fraction, but the pattern at diagnosis does not significantly affect ablation outcomes or AF recurrence rates.
Objectives: Describe the demographic, clinical, and treatment characteristics of ps-AF patients across Southwest China and assess the effectiveness and safety of various AF treatment strategies, including oral anticoagulation, electrical cardioversion, catheter ablation, and left atrial appendage closure, in routine clinical practice. Identify patient- and treatment-related factors that influence therapeutic outcomes. Explore the prevalence and treatment strategies of bradyarrhythmia in ps-AF patients. Explore the characteristics of imaging multi-omics and blood multi-omics during follow-up. Explore the role of advanced technologies and artificial intelligence in improving procedural performance, risk stratification, and clinical decision-making in AF care. Participants will undergo standardized baseline evaluation and longitudinal follow-up (prospective and retrospective) to collect data on heart rhythm monitoring, treatment exposures, healthcare utilization, clinical events, and patient-reported outcomes. This cohort will generate real-world evidence to inform personalized and evidence-based management of AF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| normal LA group | – | –the patients in this group have a normal size of left atrium. |
| enlarged LA group | – | Other: otherthe patients in this group have an enlarged size of left atrium. |
| with HF group | – | Other: otherthe patients in this group suffer from heart failure. |
| without HF group | – | –the patients in this group don't suffer from heart failure. |
| HR control group | – | –the patients in this group accept the therapy focus on heart rate control. |
| Rhythm control group | – | Other: otherthe patients in this group accept the therapy focus on rhythm control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- persistent atrial fibrillation
Key inclusion criteria (4 listed)
- Aged ≥18 years;
- diagnosed with persistent atrial fibrillation (ps-AF), defined as episodes lasting >7 days or requiring pharmacological/electrical cardioversion for rhythm restoration;
- Residing in Southwest China and capable of cooperating with long-term follow-up management;
- History of ps-AF treatment with complete medical records, and voluntary signing of the informed consent for long-term follow-up.
Key exclusion criteria (2 listed)
- Comorbid severe hepatic/renal dysfunction or malignant tumors;
- Estimated survival period <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 |
|---|---|---|
| otherThis study mainly describe the evolution and characteristic of patients with atrial fibrillation under different treatment plans and comorbidities. | Other | Rhythm control group, enlarged LA group, with HF group |
Primary outcome
Composite endpoint of stroke, major bleeding, worsening and new-onset heart failure, all-cause mortality
Time frame: 5 years
Composite endpoint of stroke, major bleeding, worsening heart failure, new-onset heart failure, and all-cause mortality
Major bleeding events, perioperative complications and adverse drug reactions
Time frame: 5 years
Major bleeding events (e.g., intracranial hemorrhage, gastrointestinal bleeding); Perioperative complications (e.g., pericardial tamponade, thrombus formation, vascular complications); Adverse drug reactions (e.g., anticoagulant-induced thrombocytopenia, amiodarone-induced thyroid dysfunction, prolonged QT interval, bradyarrhythmia, pulmonary fibrosis, etc.).
1 secondary outcome
Incidence of MACCE, SSS, AF recurrence and embolism events
Time frame: 5 years
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 2 Feb 2026.
- 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.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 2 Feb 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of stroke, major bleeding, worsening and new-onset heart failure, all-cause mortality (time frame: 5 years). The study lists 2 primary outcomes in all. 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 2 Feb 2026.