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

NCT ID: NCT04489004

Last Updated: 2023-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-12-01

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation, Persistent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Driver ablation+CPVI

Driver ablation plus CPVI (circumferential pulmonary vein isolation)

Group Type EXPERIMENTAL

Driver ablation+CPVI

Intervention Type PROCEDURE

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

Stepwise ablation

Stepwise ablation

Group Type ACTIVE_COMPARATOR

Stepwise ablation

Intervention Type PROCEDURE

Patients receive stepwise ablation.

Interventions

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Driver ablation+CPVI

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

Intervention Type PROCEDURE

Stepwise ablation

Patients receive stepwise ablation.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xu Liu

Professor, deputy director of cardiology department of Shanghai Chest Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Chest Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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Credit-AF

Identifier Type: -

Identifier Source: org_study_id

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