Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation

NCT ID: NCT04897204

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

These patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion, combined with additional left atrial appendage occlusion.

One-stop treatment of atrial fibrillation

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

Group Type: OTHER

Catheter ablation and left atrial appendage occlusion

Intervention Type: PROCEDURE

The patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion.

Interventions

Catheter ablation and left atrial appendage occlusion

The patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion.

Intervention Type: PROCEDURE

Additional 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE

UNKNOWN

Sponsor Role: collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Qun Shan Wang, Doctor

Role: CONTACT

wangqunshan@xinhuamed.com.cn

008613621878542

References

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Other Identifiers

XH-21-004

Identifier Type: -

Identifier Source: org_study_id