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

Atrial Fibrillation, Persistent Clinical Trial

Official title:

Credit-AF: A Randomized Control Study of Driver Ablation Combined With Circumferential Pulmonary Vein Isolation Versus Stepwise Ablation as a Treatment in Patients With Persistent Atrial Fibrillation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04489004
• Other study ID #: Credit-AF
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2023
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1298
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent

Intervention

Procedure:
• Driver ablation+CPVI
Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).
• Stepwise ablation
Patients receive stepwise ablation.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative atrial fibrillation (AF) recurrence rate	AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.	up to 24 months after enrollment
Primary	Procedural AF termination rate	AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).	Before the end of procedure.
Secondary	Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate	Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration.	up to 24 months after enrollment
Secondary	Incidence of complications	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.	up to 2 weeks after enrollment