Persistent Atrial Fibrillation
Conditions
Keywords
persistent atrial fibrillation, severe atrial fibrosis, catheter ablation, surgical ablation
Brief summary
This is an open label, randomized parallel control clinical trial evaluating the efficacy and safety of catheter ablation and surgical ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
Detailed description
This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into the group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion) and group C (surgical ablation). Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of catheter ablation and surgical ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
Interventions
PROCEDURECircumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation.
PROCEDURECircumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion.
PROCEDURESurgical ablation
Patients receive surgical ablation.
Sponsors
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 80 years old; 2. Persistent AF with severe atrial fibrosis; 3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.
Exclusion criteria
1. With uncontrolled congestive heart failure; 2. Having significant valvular disease; 3. With myocardial infarction or stroke within 6 months of screening; 4. With Significant congenital heart disease; 5. Ejection fraction was \<40% measured by echocardiography; 6. Allergic to contrast media; 7. Contraindication to anticoagulation medications; 8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD); 9. Left atrial (LA) thrombus; 10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation; 12\. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate | up to 12 months after enrollment | AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative AF recurrence rate | up to 12 months after enrollment | AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration |
| Postoperative AFL/AT rate | up to 12 months after enrollment | occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration |
| Incidence of complications | up to 12 months after enrollment | death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis and major vascular access complication or bleeding |
| Changes in the diameter of the left atrium and the left ventricular ejection fraction | up to 12 months after enrollment | Changes in the diameter of the left atrium and the left ventricular ejection fraction |
Contacts
Primary ContactMu Qin, M.D.
Outcome results
None listed