Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation

Shanghai Jiao Tong University

Status: Unknown

Conditions: Left Atrial Appendage Occlusion; Atrial Fibrillation; Left Atrial Appendage; Catheter Ablation

Treatments: Procedure: Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion; Procedure: Catheter ablation and left atrial appendage occlusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04897204

XH-21-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Left Atrial Appendage Electrical Isolation with One-stop treatment of atrial fibrillation

Experimental group

Description:

The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion and additional left atrial appendage electrical isolation operation.

Treatment:

Procedure: Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion

One-stop treatment of atrial fibrillation

Other group

Description:

The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion.

Treatment:

Procedure: Catheter ablation and left atrial appendage occlusion