Left Atrial Isolation by Catheter Ablation in Persistent Atrial Fibrillation With Severe Atrial Fibrosis

NCT ID: NCT05173779

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-12-31

Brief Summary

This is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Detailed Description

This is a single-arm clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Left atrial isolation arm

All the enrolled subjects will receive left atrial isolation through catheter ablation.

Group Type: EXPERIMENTAL

Left atrial isolation by catheter ablation

Intervention Type: PROCEDURE

Procedure: Right pulmonary vein circumferential isolation + anterior left atrial line (superior mitral annulus to right superior pulmonary vein via the anterior wall) + para-septal line (para-septal mitral annulus to the right inferior pulmonary vein, including right atrial components-especially in and around the proximal coronary sinus) + posterior left atrial line (superior mitral annulus to right superior pulmonary vein via the posterior wall).

Interventions

Left atrial isolation by catheter ablation

Procedure: Right pulmonary vein circumferential isolation + anterior left atrial line (superior mitral annulus to right superior pulmonary vein via the anterior wall) + para-septal line (para-septal mitral annulus to the right inferior pulmonary vein, including right atrial components-especially in and around the proximal coronary sinus) + posterior left atrial line (superior mitral annulus to right superior pulmonary vein via the posterior wall).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Aged 18 to 80 years old

2. Persistent AF with severe atrial fibrosis and left atrial anterioposterior diameter > 50mm

3. Nonresponse or intolerance to ≥1 antiarrhythmic drug

4. CHA2DS2-VASc ≥ 3 and HAS-BLED < 3

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu Liu

Professor, deputy director of cardiology department of Shanghai Chest Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mu Qin, M.D.

Role: CONTACT

qinmuae@163.com

+8613052320103

Other Identifiers

LAICA

Identifier Type: -

Identifier Source: org_study_id