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

Not Applicable

Not yet recruiting

• Conditions: Persistent Atrial Fibrillation
• Interventions: Procedure: Surgical ablation; Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation; Procedure: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion

• Registration Number: NCT05153486
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Last Update Submitted: 2021-11-29
• Study Start: 2021-12-01
• Study First Posted: 2021-12-10
• Last Update Posted: 2021-12-10
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Aged 18 to 80 years old;
2. Persistent AF with severe atrial fibrosis;
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Surgical ablation	Surgical ablation
Group A	Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation	Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation
Group B	Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion	Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion

Primary Outcome Measures

Name	Time	Method
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate	up to 12 months after enrollment	AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration

Secondary Outcome Measures

Name	Time	Method
Postoperative AF recurrence rate	up to 12 months after enrollment	AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
Postoperative AFL/AT rate	up to 12 months after enrollment	occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration
Incidence of complications	up to 12 months after enrollment	death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis and major vascular access complication or bleeding
Changes in the diameter of the left atrium and the left ventricular ejection fraction	up to 12 months after enrollment	Changes in the diameter of the left atrium and the left ventricular ejection fraction