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Stepwise Strategy for Treatment of Atrial Fibrillation Substrate Extended Study

Persistent Atrial Fibrillation in Southwest China Cohort Study-Stepwise Strategy for Treatment of Atrial Fibrillation Substrate Extended Study

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07380620
Acronym
SAFE-extended
Enrollment
5000
Registered
2026-02-02
Start date
2025-10-09
Completion date
2035-12-31
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Brief 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 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.

Interventions

OTHERother

This study mainly describe the evolution and characteristic of patients with atrial fibrillation under different treatment plans and comorbidities.

Sponsors

Yuehui Yin
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Comorbid severe hepatic/renal dysfunction or malignant tumors; * Estimated survival period \<1 year.

Design outcomes

Primary

MeasureTime frameDescription
Composite endpoint of stroke, major bleeding, worsening and new-onset heart failure, all-cause mortality5 yearsComposite endpoint of stroke, major bleeding, worsening heart failure, new-onset heart failure, and all-cause mortality
Major bleeding events, perioperative complications and adverse drug reactions5 yearsMajor 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.).

Secondary

MeasureTime frameDescription
Incidence of MACCE, SSS, AF recurrence and embolism events5 yearsIncidence 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026