Atrial Fibrillation, Catheter Ablation, Left Atrial Appendage, Left Atrial Appendage Occlusion
Conditions
Keywords
Left Atrial Appendage Electrical Isolation, Atrial Fibrillation, Catheter Ablation
Brief summary
This project intends to enroll patients with persistent atrial fibrillation who are planning to undergo catheter ablation of atrial fibrillation. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. We are intend to evaluate the safety and effectiveness of one-stop operation of left atrial appendage electrical isolation combined with left atrial appendage occlusion in the treatment of persistent atrial fibrillation.
Detailed description
This project intends to enroll patients with persistent atrial fibrillation who are planned to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery, and randomly allocate them to the experimental group and the control group at a ratio of 1:1. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. Follow-up for 1 year, compare the differences in the recurrence rate of atrial fibrillation between the two groups of patients, and further compare the differences in clinical events such as stroke, systemic embolism, hospitalization due to heart failure, and cardiovascular death.
Interventions
PROCEDURECatheter ablation and left atrial appendage occlusion
The patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion.
PROCEDUREAdditional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion
These patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion, combined with additional left atrial appendage occlusion.
Sponsors
ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-85 years old; 2. Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥ 1 week), and is ineffective to one or more anti-arrhythmic drugs; 3. CHA2DS2-VASc score ≥ 2 points; 4. The patient is ready to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery; 5. Provide an informed consent form that is willing to participate in the research, follow-up trials and evaluation procedures.
Exclusion criteria
1. Past left atrial appendage occlusion, atrial fibrillation catheter ablation or surgical ablation history; 2. There are plans for cardiac surgery within 90 days; 3. Stroke/transient ischemic attack occurred within 30 days; 4. Have had atrial septal defect repair or have an ASD/PFO occluder in the body; 5. Heart failure NYHA heart function grade IV; 6. LVEF\<30%; 7. Combined with other serious diseases, the life expectancy is less than 2 years; 8. Within 6 months after cardiac revascularization or other cardiac surgery; 9. Women who are pregnant, breastfeeding, planning to become pregnant, or women of childbearing age who have not adopted reliable contraceptive methods; 10. Obviously abnormal liver and kidney function and coagulation function;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation recurrence | one year after operation | outside the 3-month blank period after surgery, ECG and Holter recorded rapid atrial arrhythmia greater than 30S. |
| Stroke/TIA | one year after operation | Patients may have cerebral ischemia, such as sudden limb movement and sensory disturbance, aphasia, transient blindness in one eye, etc., disturbance of consciousness, or symptoms of vertebral artery ischemia, such as vertigo, tinnitus, hearing impairment, diplopia, Unsteady gait and difficulty swallowing, etc., patients may have obvious infarcts in the brain, which can be confirmed clinically by CT or MRI. |
| Systemic embolism | one year after operation | The clinical manifestations or evidence of embolism in the blood vessels of the system, including renal artery, splenic artery, mesenteric artery, etc. during the follow-up of the patient, and relevant examinations can be used to confirm the diagnosis. |
| Cardiovascular death | one year after operation | The death of a patient due to cardiac structure, function, coronary artery disease, and arrhythmia can be diagnosed in combination with clinical practice. |
| Hospitalization rate due to heart failure | one year after operation | During the follow-up period, patients need hospitalization for heart failure, including acute heart failure, acute exacerbation of chronic heart failure, etc., which can be combined with clinical symptoms, signs, biochemical examinations (such as NT-proBNP) and cardiac ultrasound Wait for a clear diagnosis. |
Contacts
Primary ContactQun Shan Wang, Doctor
Outcome results
None listed