Catheter Ablation and Surgical Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Surgical ablation; Procedure: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion; Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05153486

DAAF II

Details and patient eligibility

About

This is an open label, randomized parallel control clinical trial evaluating the efficacy and safety of catheter ablation and surgical ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Full description

This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into the group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion) and group C (surgical ablation). Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of catheter ablation and surgical ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

Enrollment: 300 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;
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Exclusion criteria

1. With uncontrolled congestive heart failure;

2. Having significant valvular disease;

3. With myocardial infarction or stroke within 6 months of screening;

4. With Significant congenital heart disease;

5. Ejection fraction was <40% measured by echocardiography;

6. Allergic to contrast media;

7. Contraindication to anticoagulation medications;

8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);

9. Left atrial (LA) thrombus;

10. Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;

11. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 3 patient groups

Group A

Experimental group

Description:

Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation

Treatment:

Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation

Group B

Active Comparator group

Description:

Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion

Treatment:

Procedure: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion

Group C

Active Comparator group

Description:

Surgical ablation

Treatment:

Procedure: Surgical ablation