Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation

Not Applicable

• Conditions: Atrial Fibrillation; Left Atrial Appendage; Catheter Ablation; Left Atrial Appendage Occlusion
• Interventions: Procedure: Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion; Procedure: Catheter ablation and left atrial appendage occlusion

• Registration Number: NCT04897204
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-19
• Last Update Submitted: 2021-05-19
• Study First Posted: 2021-05-21
• Last Update Posted: 2021-05-21
• Study Start: 2021-06-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Atrial Appendage Electrical Isolation with One-stop treatment of atrial fibrillation	Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion	The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion and additional left atrial appendage electrical isolation operation.
One-stop treatment of atrial fibrillation	Catheter ablation and left atrial appendage occlusion	The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.