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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Left atrial isolation by catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05173779

LAICA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Left atrial isolation arm

Experimental group

Description:

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

Treatment:

Procedure: Left atrial isolation by catheter ablation