Atrial Fibrillation, Atrial Fibrillation, Persistent
Conditions
Keywords
linear ablation
Brief summary
Based on previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. population size is 207. The participants will be randomized to the linear ablation group and PVI ablation group with a 2:1 ratio. the follow-up period is 12 months. The primary outcome is freedom from atrial fibrillation, the secondary outcome is complications related to ablation.
Detailed description
Pulmonary vein isolation is recommended as the cornerstone of catheter ablation of atrial fibrillation by current guidelines, However, meta-analysis suggests that the success rate of continuous pulmonary vein isolation for persistent atrial fibrillation is only 43%. Therefore, in addition to pulmonary vein isolation, further research on substrate modification in the treatment of atrial fibrillation is particularly important. Based on our previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. The linear ablation is performed on the basis of Ω-type linear ablation. Further stepwise ablation of the left atrial anterior wall increases the blockage of the LA roof and the MVA isthmus. Ablation in CS or ethanol ablation of vein of Marshall. Also, epicardial ablation on the roof or rigid between LAA-LPVs may be applied if necessary.
Interventions
PROCEDUREcatheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)
individualized stepwise linear ablation without pulmonary vein isolation
PROCEDUREcatheter radiofrequency ablation(PVI)
pulmonary vein isolation
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE
Beijing Hospital
Wuhan Asia Heart Hospital
Tianjin Medical University General Hospital
Fuwai Yunnan Cardiovascular Hospital
RenJi Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients suffering from persistent atrial fibrillation and referred to catheter ablation therapy. * patients agreeing to be enrolled， with the informed consent signed
Exclusion criteria
1. Sinus rhythm at the time of recruitment; 2. Age less than 18 years old or older than 75 years; 3. Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 55 mm; 4. History of previous radiofrequency ablation of atrial fibrillation or surgical ablation History; 5. Left atrial thrombus recorded by ultrasound or CT; 6. Combined with severe lung disease; 7. Previous history of cardiac surgery; 8. Patients with hyperthyroidism, atrial septal defect, mitral stenosis, or severe coronary heart disease requiring further treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from atrial fibrillation at 1 year | 12 months after the ablation | Recurrent AF is defined as documented AF (through 12-lead ECG) episode lasting \>30 seconds after a 3-month blanking period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complications related to ablation | 12 months after the ablation | Tamponade, pericarditis and perforation following the ablation procedure |
Countries
China
Outcome results
None listed