Stepwise Strategy for Treatment of Atrial Fibrillation Substrate Extended Study (SAFE-extended)

Yuehui Yin

Status: Invitation-only

Conditions: Atrial Fibrillation

Treatments: Other: other

Study type: Observational

Funder types: Other

Identifiers

NCT07380620

SAFE-extended study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

5,000 participants in 6 patient groups

normal LA group

Description:

the patients in this group have a normal size of left atrium.

enlarged LA group

Description:

the patients in this group have an enlarged size of left atrium.

Treatment:

Other: other

with HF group

Description:

the patients in this group suffer from heart failure.

Treatment:

Other: other

without HF group

Description:

the patients in this group don't suffer from heart failure.

HR control group

Description:

the patients in this group accept the therapy focus on heart rate control.

Rhythm control group

Description:

the patients in this group accept the therapy focus on rhythm control.

Treatment:

Other: other