Atrial Fibrillation Patients Treated With Catheter Ablation
- Conditions
- Atrial Fibrillation RecurrentAtrial Fibrillation
- Interventions
- Procedure: radiofrequency ablation
- Registration Number
- NCT05266144
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- Intra-atrial thrombus detected by TEE
- Hyperthyroidism
- Previous radiofrequency ablation for atrial fibrillation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description atrial fibrillation radiofrequency ablation Atrial fibrillation patients who underwent radiofrequency ablation in Peking Union Medical College Hospital.
- Primary Outcome Measures
Name Time Method Recurrence assessed by ECG, Holter reports and outpatient physicians at 1-year follow-up after ablation Recurrence 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 records at 1-year follow-up after ablation Time and cause of death will be recorded.
- Secondary Outcome Measures
Name Time Method Improvement in life quality assessed by QOLSF36 Questionnaire at 1-year follow-up after ablation Life quality will be assessed at baseline and 1-year FU. Improvement in life quality indicates that patients can benefit from the catheter ablation.
Embolic events assessed by physicians and further examinations like ultrasound, MRI at 1-year follow-up after ablation 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.
Improvement in left atrial function assessed by echocardiography at 1-year follow-up after ablation Left atrial function will be assessed at baseline and 1-year FU. Improvement in atrial function indicates that ablation can restore atrial function.
Hospitalization for heart failure, atrial fibrillation or atrial flutter at 1-year follow-up after ablation Postoperative hospitalization indicate worse prognosis.
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China