Atrial Fibrillation Patients Treated With Catheter Ablation

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05266144
• Other study ID #: PUMCH-AF
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Recurrent

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