Atrial Fibrillation Patients Treated With Catheter Ablation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital
About this trial
This is a single-center prospective observational cohort study of atrial fibrillation patients treated with radiofrequency ablation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Intra-atrial thrombus detected by TEE
Hyperthyroidism
Previous radiofrequency ablation for atrial fibrillation
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
radiofrequency ablation
Procedure/SurgeryBilateral pulmonary vein isolation, a kind of radiofrequency ablation, is performed in atrial fibrillation patients for atrial arrhythmia therapy.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: atrial fibrillation1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
at 1-year follow-up after ablation2
All-cause mortality assessed by telephone follow-up or medical records
Time and cause of death will be recorded.
Time frame
at 1-year follow-up after ablationSecondary outcomes
1
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.
Time frame
at 1-year follow-up after ablation2
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.
Time frame
at 1-year follow-up after ablation3
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.
Time frame
at 1-year follow-up after ablation4
Hospitalization for heart failure, atrial fibrillation or atrial flutter
Postoperative hospitalization indicate worse prognosis.
Time frame
at 1-year follow-up after ablationSponsors and contacts
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Source ClinicalTrials.gov