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

Primary Purpose

Atrial Fibrillation, Persistent

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Driver ablation+CPVI

Stepwise ablation

About this trial

This is an interventional treatment trial for Atrial Fibrillation, Persistent focused on measuring Persistent Atrial Fibrillation, Driver ablation, Stepwise ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

With uncontrolled congestive heart failure;
Having significant valvular disease and/or prosthetic heart valve(s);
With myocardial infarction or stroke within 6 months of screening;
With Significant congenital heart disease;
Ejection fraction was <40% measured by echocardiography;
Allergic to contrast media;
Contraindication to anticoagulation medications;
Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;
Having any contraindication to right or left sided heart catheterization;
Previous atrial fibrillation ablation;
Presence of an implanted cardioverter-defibrillator;
Any cardiac surgery within the past 2 months;
Poor general health;
Life expectancy less than 6 months.

Sites / Locations

Shanghai Chest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Driver ablation+CPVI

Stepwise ablation

Arm Description

Driver ablation plus CPVI (circumferential pulmonary vein isolation)

Stepwise ablation

Outcomes

Primary Outcome Measures

Postoperative atrial fibrillation (AF) recurrence rate

AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.

Procedural AF termination rate

AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04489004

First Posted

July 24, 2020

Last Updated

February 2, 2023

Sponsor

Shanghai Chest Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04489004

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

December 1, 2021 (Actual)

Study Completion Date

December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Chest Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Persistent

Keywords

Persistent Atrial Fibrillation, Driver ablation, Stepwise ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1298 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Driver ablation+CPVI

Arm Type

Experimental

Arm Description

Driver ablation plus CPVI (circumferential pulmonary vein isolation)

Arm Title

Stepwise ablation

Arm Type

Active Comparator

Arm Description

Stepwise ablation

Intervention Type

Procedure

Intervention Name(s)

Driver ablation+CPVI

Intervention Description

Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).

Intervention Type

Procedure

Intervention Name(s)

Stepwise ablation

Intervention Description

Patients receive stepwise ablation.

Primary Outcome Measure Information:

Title

Postoperative atrial fibrillation (AF) recurrence rate

Description

AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.

Time Frame

up to 24 months after enrollment

Title

Procedural AF termination rate

Description

AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).

Time Frame

Before the end of procedure.

Secondary Outcome Measure Information:

Title

Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate

Description

Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration.

Time Frame

up to 24 months after enrollment

Title

Incidence of complications

Description

Time Frame

up to 2 weeks after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 18 to 80 years old; Persistent AF; nonresponse or intolerance to ≥1 antiarrhythmic drug. - Exclusion Criteria: With uncontrolled congestive heart failure; Having significant valvular disease and/or prosthetic heart valve(s); With myocardial infarction or stroke within 6 months of screening; With Significant congenital heart disease; Ejection fraction was <40% measured by echocardiography; Allergic to contrast media; Contraindication to anticoagulation medications; Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD); Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography; Having any contraindication to right or left sided heart catheterization; Previous atrial fibrillation ablation; Presence of an implanted cardioverter-defibrillator; Any cardiac surgery within the past 2 months; Poor general health; Life expectancy less than 6 months.

Facility Information:

Facility Name

Shanghai Chest Hospital

City

Shanghai

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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