Persistent Atrial Fibrillation
Conditions
Keywords
persistent atrial fibrillation, catheter ablation, CARTO-Finder-guided ablation, Multiscale entropy-guided ablation
Brief summary
This is a randomized control trial to compare the efficacy and safety of CARTO-Finder-guided ablation plus pulmonary vein isolation versus multiscale entropy (MSE)-guided pulmonary vein isolation in patients with persistent atrial fibrillation.
Detailed description
This is a randomized control trial. Patients with persistent atrial fibrillation are enrolled and randomized to CARTO-Finder-guided ablation plus PVI group or MSE-guided ablation plus PVI group. Postoperative recurrence rate and other indicators are analyzed to compare the efficacy and safety between CARTO-Finder-guided ablation plus PVI and MSE-guided ablation plus PVI in patients with persistent atrial fibrillation.
Interventions
PROCEDUREMultiscale entropy-guided ablation plus PVI
The multiscale entropy is calculated based on intracardiac electrical signals, higher multiscale entropy value indicates closer to the core of rotors which maintains the persistent atrial fibrillation.
PROCEDURECARTO-Finder-guided ablation plus PVI
CARTO-Finder-guided ablation plus PVI
Sponsors
Shandong University of Traditional Chinese Medicine
Department of Cardiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Wuhan Central Hospital
Department of Cardiology, Affiliated Hospital of Jining Medical University
Department of Cardiology, Yuhuan Second People's Hospital
Department of Cardiology, Changshu Hospital of Traditional Chinese Medicine
Department of Cardiology, The PLA Navy Anqing Hospital
Department of Cardiology, Jinan City People's Hospital
Department of Cardiology, Xuzhou Central Hospital
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
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 3. Nonresponse or intolerance to ≥1 antiarrhythmic drug
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 24 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 24 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 24 months after enrollment | Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in the diameter of the left atrium | up to 24 months after enrollment | Changes in the diameter of the left atrium |
| Changes in the diameter of the left ventricular ejection fraction | up to 24 months after enrollment | Changes in the diameter of the left ventricular ejection fraction |
| Incidence of complications | up to 24 months after enrollment | 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 |
Countries
China
Contacts
Primary ContactXu Liu, M.D.
Outcome results
None listed