Persistent Atrial Fibrillation
Conditions
Keywords
Persistent Atrial Fibrillation, Severe atrial fibrosis, Left atrial isolation, catheter ablation
Brief summary
This is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
Detailed description
This is a single-arm clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
Interventions
PROCEDURELeft atrial isolation by catheter ablation
Procedure: Right pulmonary vein circumferential isolation + anterior left atrial line (superior mitral annulus to right superior pulmonary vein via the anterior wall) + para-septal line (para-septal mitral annulus to the right inferior pulmonary vein, including right atrial components-especially in and around the proximal coronary sinus) + posterior left atrial line (superior mitral annulus to right superior pulmonary vein via the posterior wall).
Sponsors
Shanghai Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 and left atrial anterioposterior diameter \> 50mm 3. Nonresponse or intolerance to ≥1 antiarrhythmic drug 4. CHA2DS2-VASc ≥ 3 and HAS-BLED \< 3
Exclusion criteria
1. With uncontrolled congestive heart failure; 2. Having significant valvular disease; 3. Having moderate-to-severe pulmonary hypertension; 4. With myocardial infarction or stroke within 6 months of screening; 5. With Significant congenital heart disease; 6. Ejection fraction was \<40% measured by echocardiography; 7. Allergic to contrast media; 8. Contraindication to anticoagulation medications; 9. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD); 10. Left atrial thrombus; 11. Having any contraindication to right or left sided heart catheterization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate | up to 18 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 18 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 18 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 18 months after enrollment | including death, atrio-esophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, left atrial thrombus, pericarditis and major vascular access complication or bleeding |
| Changes in the diameter of the left atrium and the left ventricular ejection fraction | up to 18 months after enrollment | — |
Contacts
Primary ContactMu Qin, M.D.
Outcome results
None listed