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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05266144
Other study ID # PUMCH-AF
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 4, 2020
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source Peking Union Medical College Hospital
Contact Yongtai Liu, M.D.
Phone +86-1069155068
Email ataiever@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Improvement in life quality assessed by QOLSF36 Questionnaire 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
Secondary Improvement in left atrial function assessed by echocardiography 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
Secondary Embolic events assessed by physicians and further examinations like ultrasound, MRI 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
Secondary Hospitalization for heart failure, atrial fibrillation or atrial flutter Postoperative hospitalization indicate worse prognosis. at 1-year follow-up after ablation
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