Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.

Not Applicable

Not yet recruiting

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

• Registration Number: NCT05085912
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

This is an open label, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy 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 group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation) and group C (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion). Postoperative recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-18
• Last Update Submitted: 2021-10-18
• Study First Posted: 2021-10-20
• Last Update Posted: 2021-10-20
• Study Start: 2021-11-01
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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 + posterior wall box isolation	Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation
Group C	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 ablation	AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
Intraoperative AF termination rate	through ablation completion, an average of 3 hours	AF termination is defined as conversion to sinus rhythm or stable AFL/AT.

Secondary Outcome Measures

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