NCT05266144

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Start

First participant enrolled

September 4, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 5, 2025

Status Verified

February 1, 2025

Enrollment Period

5.1 years

First QC Date

February 13, 2022

Last Update Submit

June 4, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Recurrence assessed by ECG, Holter reports and outpatient physicians

    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 and cause of death will be recorded.

    at 1-year follow-up after ablation

Secondary Outcomes (4)

  • Improvement in life quality assessed by QOLSF36 Questionnaire

    at 1-year follow-up after ablation

  • Improvement in left atrial function assessed by echocardiography

    at 1-year follow-up after ablation

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

    at 1-year follow-up after ablation

  • Hospitalization for heart failure, atrial fibrillation or atrial flutter

    at 1-year follow-up after ablation

Study Arms (1)

atrial fibrillation

Atrial fibrillation patients who underwent radiofrequency ablation in Peking Union Medical College Hospital.

Procedure: radiofrequency ablation

Interventions

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

atrial fibrillation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Non-valvular atrial fibrillation, including paroxysmal atrial fibrillation and persistent atrial fibrillation
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be used for biochemical parameter analysis, and atrial fibrillation patients with ventricular fibrosis will be selected for gene sequencing to explore the existence of underlying cardiomyopathy.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Quan Fang, M.D.

    Peking Union Medical College Hospital

    STUDY CHAIR
  • Yongtai Liu, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongtai Liu, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2022

First Posted

March 4, 2022

Study Start

September 4, 2020

Primary Completion

October 1, 2025

Study Completion

December 31, 2025

Last Updated

June 5, 2025

Record last verified: 2025-02

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