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

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.

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation, Persistent
• Intervention / Treatment: Procedure: Driver ablation+CPVI; Procedure: Stepwise ablation

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 Type: Interventional
• Enrollment (Actual): 1298
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Chest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Driver ablation+CPVI; Driver ablation plus CPVI (circumferential pulmonary vein isolation)	Procedure: Driver ablation+CPVI; Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).
ACTIVE_COMPARATOR: Stepwise ablation	Procedure: Stepwise ablation; Patients receive stepwise ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 1, 2022

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (ACTUAL): July 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Persistent Atrial Fibrillation; Driver ablation; Stepwise ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Credit-AF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes