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NCT Number: NCT05266144

Atrial Fibrillation Patients Treated With Catheter Ablation

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Recurrent Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency ablation

Procedure

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

Primary outcomes

  1. Recurrence assessed by ECG, Holter reports and outpatient physicians

    Time frame: at 1-year follow-up after ablation

    Recurrence includes atrial fibrillation and atrial flutter. Recurrence features including pattern, duration, burden, etc. will be recorded.

  2. All-cause mortality assessed by telephone follow-up or medical records

    Time frame: at 1-year follow-up after ablation

    Time and cause of death will be recorded.

Secondary outcomes

  1. Improvement in life quality assessed by QOLSF36 Questionnaire

    Time frame: at 1-year follow-up after ablation

    Life quality will be assessed at baseline and 1-year FU. Improvement in life quality indicates that patients can benefit from the catheter ablation.

  2. Improvement in left atrial function assessed by echocardiography

    Time frame: at 1-year follow-up after ablation

    Left atrial function will be assessed at baseline and 1-year FU. Improvement in atrial function indicates that ablation can restore atrial function.

  3. Embolic events assessed by physicians and further examinations like ultrasound, MRI

    Time frame: at 1-year follow-up after ablation

    Embolism may be related to atrial fibrillation. Embolism will be assessed by physicians according to patients' symptoms and signs at clinic or by telephone. If a patient's clinical presentation indicates embolism, the patient will be further assessed by ultrasound, MRI, etc.

  4. Hospitalization for heart failure, atrial fibrillation or atrial flutter

    Time frame: at 1-year follow-up after ablation

    Postoperative hospitalization indicate worse prognosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Yongtai Liu, M.D.

CONTACT

[email protected]

+86-1069155068

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2022
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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