Atrial Fibrillation, Atrial Remodeling
Conditions
Keywords
catheter ablation
Brief summary
This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.
Interventions
PROCEDURECPVI
Circumferential PV isolation only
PROCEDURECPVI+BOX
Circumferential PV and BOX isolation
PROCEDURECPVI+BOX+SUB
Atrial substrate ablation apart from circumferential PV and BOX isolation
Sponsors
The Third Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent signed. * Age of 18 to 75 years old. * Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months. * Willing to have catheter ablation for atrial fibrillation.
Exclusion criteria
* Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on. * Complete atrioventricular block. * An acute stroke or contradiction of anti-coagulation. * Hyperthyroidism. * Having a history of catheter ablation of atrial fibrillation. * Left atrial appendage thrombosis confirmed by transesophageal echocardiography. * Pregnancy or lactation. * Planning for pregnancy in the near future. * Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal. * Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sinus rhythm maintenance rate | 12 months | Holter is performed 12months after the procedure and heart rhythm is recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| left ventricular ejection fraction | 12 months | LVEF is evaluated by echocardiography 12months after the procedure. |
| Stroke or embolic events | 12 months | History of stroke or embolic events is taken at each follow-up during the period of 12 months after procedure, and if necessary, radiographic examinations will be performed. |
| Atrial fibrosis | 1 day | Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis. |
Outcome results
None listed