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Enrolling by invitationNCT07380620SAFE-extendedUpdated Feb 2, 2026

Stepwise Strategy for Treatment of Atrial Fibrillation Substrate Extended Study

An observational study in Atrial Fibrillation, sponsored by Yuehui Yin. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Yuehui Yin · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
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Study 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.

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.

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Conditions studied

  • Atrial Fibrillation

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Keywords

  • Atrial Fibrillation
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Yuehui Yin is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

persistent atrial fibrillation

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otherother

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 years

  2. 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.).

    Time frame: 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.

    Time frame: 5 years

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Study locations

1 site
  • the second affiliated hospital of CQMU
    Chongqing, China
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References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07380620
Lead sponsor
Yuehui Yin
Responsible party
Yuehui Yin (MD, The Second Affiliated Hospital of Chongqing Medical University) — Sponsor-investigator
First posted
Feb 2, 2026
Start date
Oct 9, 2025
Primary completion
Oct 9, 2035 (estimated)
Completion
Dec 31, 2035 (estimated)
Last update
Feb 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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