Stepwise Strategy for Treatment of Atrial Fibrillation Substrate Extended Study

NCT07380620 | Enrolling By Invitation

• 1 other identifier: SAFE-extended study
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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

  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.).

  5 years

Secondary Outcomes (1)

• Incidence of MACCE, SSS, AF recurrence and embolism events

  5 years

Study Arms (6)

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.

Other: other

with HF group

the patients in this group suffer from heart failure.

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.

Other: other

Interventions

other OTHER

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

Rhythm control group; enlarged LA group; with HF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

persistent atrial fibrillation

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yuehui Yin: lead

Study Sites (1)

the second affiliated hospital of CQMU

Chongqing, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: February 2, 2026
• Study Start: October 9, 2025
• Primary Completion (Estimated): October 9, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)