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Atrial Fibrillation Patients Treated With Catheter Ablation

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05266144
Enrollment
300
Registered
2022-03-04
Start date
2020-09-04
Completion date
2025-12-31
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Atrial Fibrillation Recurrent

Brief summary

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

PROCEDUREradiofrequency ablation

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

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence assessed by ECG, Holter reports and outpatient physiciansat 1-year follow-up after ablationRecurrence includes atrial fibrillation and atrial flutter. Recurrence features including pattern, duration, burden, etc. will be recorded.
All-cause mortality assessed by telephone follow-up or medical recordsat 1-year follow-up after ablationTime and cause of death will be recorded.

Secondary

MeasureTime frameDescription
Improvement in life quality assessed by QOLSF36 Questionnaireat 1-year follow-up after ablationLife quality will be assessed at baseline and 1-year FU. Improvement in life quality indicates that patients can benefit from the catheter ablation.
Improvement in left atrial function assessed by echocardiographyat 1-year follow-up after ablationLeft atrial function will be assessed at baseline and 1-year FU. Improvement in atrial function indicates that ablation can restore atrial function.
Embolic events assessed by physicians and further examinations like ultrasound, MRIat 1-year follow-up after ablationEmbolism 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.
Hospitalization for heart failure, atrial fibrillation or atrial flutterat 1-year follow-up after ablationPostoperative hospitalization indicate worse prognosis.

Countries

China

Contacts

Primary ContactYongtai Liu, M.D.
ataiever@163.com+86-1069155068

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026