Atrial Fibrillation Patients Treated With Catheter Ablation

June 4, 2025 updated by: Peking Union Medical College Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100005
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive atrial fibrillation patients, who underwent catheter ablation in Peking Union Medical College Hospital, were enrolled. All patients went through bilateral pulmonary vein isolation under general or local anesthesia, and were regularly followed up at 3-month and 1-year after ablation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
atrial fibrillation
Atrial fibrillation patients who underwent radiofrequency ablation in Peking Union Medical College Hospital.
Procedure: radiofrequency ablation
Bilateral pulmonary vein isolation, a kind of radiofrequency ablation, is performed in atrial fibrillation patients for atrial arrhythmia therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Time and cause of death will be recorded.
at 1-year follow-up after ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 1-year follow-up after ablation
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.
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
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.
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
Postoperative hospitalization indicate worse prognosis.
at 1-year follow-up after ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Quan Fang, M.D., Peking Union Medical College Hospital
  • Principal Investigator: Yongtai Liu, M.D., Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2020

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 13, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-AF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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