NCT06987825

Brief Summary

This prospective, observational cohort study aims to establish a long-term registry of adult patients with atrial fibrillation (AF) in China to comprehensively characterize patient profiles and evaluate real-world management and outcomes over time. The objectives of the study are to:

  • Describe the demographic, clinical, and treatment characteristics of AF patients across different stages of disease progression.
  • Assess the effectiveness and safety of various AF treatment strategies, including oral anticoagulation, catheter ablation, and left atrial appendage closure, in routine clinical practice.
  • Identify patient- and treatment-related factors that influence therapeutic outcomes.
  • 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
114mo left

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Aug 2011Dec 2035

Study Start

First participant enrolled

August 1, 2011

Completed
13.8 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2035

Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

24.4 years

First QC Date

May 16, 2025

Last Update Submit

May 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    Death due to any cause.

    10 years

Secondary Outcomes (9)

  • Ischemic Stroke

    5 years

  • Hemorrhagic Stroke

    5 years

  • Transient ischemic attack (TIA)

    5 years

  • Cardiovascular Death

    5 years

  • Cardiovascular Hospitalization

    5 years

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults (≥18 years) with documented atrial fibrillation enrolled from multiple hospitals across China.

You may qualify if:

  • Age ≥ 18 years;
  • Documented atrial fibrillation episode lasting \>30 seconds confirmed by electrocardiogram (ECG), Holter monitor, implantable cardiac monitor, or wearable ECG device
  • Signed informed consent and willingness to participate in follow-up

You may not qualify if:

  • Atrial fibrillation due to a reversible cause (e.g., transient secondary AF)
  • Presence of comorbid conditions associated with an expected life expectancy of less than 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Changsheng Ma, MD

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2025

First Posted

May 23, 2025

Study Start

August 1, 2011

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2035

Last Updated

May 23, 2025

Record last verified: 2025-05

Locations