Clinical trial NCT05266144: Atrial Fibrillation Patients Treated With Catheter Ablation
Official title: A Prospective Cohort Study of Atrial Fibrillation Patients Treated With Catheter Ablation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Atrial Fibrillation Recurrent
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence assessed by ECG, Holter reports and outpatient physicians
timeFrame: at 1-year follow-up after ablation
measure: All-cause mortality assessed by telephone follow-up or medical records
timeFrame: at 1-year follow-up after ablation
Secondary outcomes:
measure: Improvement in life quality assessed by QOLSF36 Questionnaire
timeFrame: at 1-year follow-up after ablation
measure: Improvement in left atrial function assessed by echocardiography
timeFrame: at 1-year follow-up after ablation
measure: Embolic events assessed by physicians and further examinations like ultrasound, MRI
timeFrame: at 1-year follow-up after ablation
measure: Hospitalization for heart failure, atrial fibrillation or atrial flutter
timeFrame: at 1-year follow-up after ablation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Quan Fang, M.D.
role: STUDY_CHAIR
affiliation: Peking Union Medical College Hospital
name: Yongtai Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: