The Chinese Registration Study of Driver Ablation of Persistent Atrial Fibrillation.

Not Applicable

Completed

• Conditions: Atrial Fibrillation, Persistent
• Interventions: Procedure: Stepwise ablation; Procedure: Driver ablation+CPVI

• Registration Number: NCT04489004
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

This is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.

Detailed Description

This is an open label, multi-center, randomized parallel control clinical trial. Patients with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation). Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.

Study Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-28
• Study Start: 2020-08-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1298

Inclusion Criteria

1. Aged 18 to 80 years old;
2. Persistent AF;
3. nonresponse or intolerance to ≥1 antiarrhythmic drug. -

Exclusion Criteria

1. With uncontrolled congestive heart failure;
2. Having significant valvular disease and/or prosthetic heart valve(s);
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 measured by pre-procedure transesophageal echocardiography;
10. Having any contraindication to right or left sided heart catheterization;
11. Previous atrial fibrillation ablation;
12. Presence of an implanted cardioverter-defibrillator;
13. Any cardiac surgery within the past 2 months;
14. Poor general health;
15. Life expectancy less than 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stepwise ablation	Stepwise ablation	Stepwise ablation
Driver ablation+CPVI	Driver ablation+CPVI	Driver ablation plus CPVI (circumferential pulmonary vein isolation)

Primary Outcome Measures

Name	Time	Method
Postoperative atrial fibrillation (AF) recurrence rate	up to 24 months after enrollment	AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.
Procedural AF termination rate	Before the end of procedure.	AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).

Secondary Outcome Measures

Name	Time	Method
Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate	up to 24 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 2 weeks after enrollment	Complications include: death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack (TIA), diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis, and major vascular access complication or bleeding.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China