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Recruiting NCT05266144

Atrial Fibrillation Patients Treated With Catheter Ablation

Observational Atrial Fibrillation Atrial Fibrillation Recurrent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: radiofrequency ablation.
Who it may be relevant to
Registry conditions: Atrial Fibrillation, Atrial Fibrillation Recurrent. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Prospective Cohort Study of Atrial Fibrillation Patients Treated With Catheter Ablation

Overview

This is a single-center prospective observational cohort study of atrial fibrillation patients treated with radiofrequency ablation.

Detailed description

The effect of radiofrequency therapy on the life quality and atrial function of atrial fibrillation patients will be assessed, through the multidimensional analysis of baseline clinical data, serological indicators of atrial fibrosis, echocardiography, cardiac magnetic resonance imaging, atrial potential mapping, life quality, and long-term ECG monitoring within 1 week after radiofrequency ablation. A predictive model for atrial fibrillation recurrence after ablation will be established. Based on the cross-sectional analysis of baseline data, the relationship between non-invasive assessment of atrial fibrosis (imaging and serology), atrial electrical activity, and atrial function will be analyzed as well, and atrial fibrillation patients with ventricular fibrosis will be selected for gene sequencing to explore the existence of underlying cardiomyopathy and provide data for further research.

Interventions

  • Procedure radiofrequency ablation
    Bilateral pulmonary vein isolation, a kind of radiofrequency ablation, is performed in atrial fibrillation patients for atrial arrhythmia therapy.

Primary outcome measures

  • Recurrence assessed by ECG, Holter reports and outpatient physicians [Time frame: at 1-year follow-up after ablation]
  • All-cause mortality assessed by telephone follow-up or medical records [Time frame: at 1-year follow-up after ablation]
Secondary outcome measures (4)
  • Improvement in life quality assessed by QOLSF36 Questionnaire [Time frame: at 1-year follow-up after ablation]
  • Improvement in left atrial function assessed by echocardiography [Time frame: at 1-year follow-up after ablation]
  • Embolic events assessed by physicians and further examinations like ultrasound, MRI [Time frame: at 1-year follow-up after ablation]
  • Hospitalization for heart failure, atrial fibrillation or atrial flutter [Time frame: at 1-year follow-up after ablation]

Eligibility criteria

Inclusion criteria

  • Non-valvular atrial fibrillation, including paroxysmal atrial fibrillation and persistent atrial fibrillation
  • 18-80 years old
  • The anteroposterior diameter of the left atrium is less than 50mm via TTE
  • Patient meets the intervention criteria for bilateral pulmonary vein isolation after evaluation by electrophysiological specialists
  • Patient consents to ablation treatment

Exclusion criteria

  • Intra-atrial thrombus detected by TEE
  • Hyperthyroidism
  • Previous radiofrequency ablation for atrial fibrillation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Publications

  • Lai J, Qin X, Zhang D, Wang J, Yu J, Sun K, Yang D, Fan J, Zhang L, Cheng Z, Cheng K, Gao P, Deng H, Fang L, Chen T, Fang Q, Liu Y. The diagnostic value of left atrial stiffness for heart failure with preserved ejection fraction in patients with paroxysmal atrial fibrillation. Echo Res Pract. 2026 Feb 23;13(1):6. doi: 10.1186/s44156-026-00107-5. PMID 41725017
  • Sun K, Qin X, Zhang D, Fang F, Wan R, Wang J, Yu J, Lai J, Yang D, Fan J, Cheng Z, Cheng K, Gao P, Zhang L, Deng H, Fang Q, Chen T, Liu Y. HFpEF correlated with better improvement of left atrial function in post-ablation patients with paroxysmal atrial fibrillation. Int J Cardiovasc Imaging. 2025 Apr;41(4):721-732. doi: 10.1007/s10554-025-03359-0. Epub 2025 Mar 1. PMID 40025277

Identifiers

NCT: NCT05266144 · PUMCH-AF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗