A Randomized Controlled Study of Ablation Pursuing Atrial Fibrillation Termination as a Procedural Endpoint in Patients With Persistent Atrial Fibrillation

NCT ID: NCT05921734

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-08-01

Brief Summary

This is a prospective, randomized, multi-center trial that aims to investigate whether termination of atrial fibrillation can be used as an ablation endpoint for persistent atrial fibrillation (PersAF). Eligible patients who provided consent were randomly assigned to one of two groups: the AF-termination group (whose ablation endpoint was the pursuit of AF-termination) or the prespecified-ablation group (whose ablation endpoint was prespecified ablation followed by electrical cardioversion).

Conditions

Atrial Fibrillation; Cathter Ablation; Endpoint

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AF-termination Group

Group Type: EXPERIMENTAL

AF-termination Group

Intervention Type: PROCEDURE

Each center completes the ablation according to the above ablation procedure. The choice of ablation strategy is not restricted, but efforts should be made to achieve termination of AF during the ablation procedure. If cannot terminate AF for safety or other reasons involving difficulties to remap AFEGM or creating a complete conduction block despite the operator's best efforts, then direct current conversion (DCCV) was performed.

Prespecified-ablation Group

Group Type: ACTIVE_COMPARATOR

Prespecified-ablation Group

Intervention Type: PROCEDURE

Each center completes the prespecified ablation according to the above ablation procedure. Although there is no restriction on the choice of ablation strategy, Ablation must be performed following the PVI plus strategy, which can be combined with one or more additional ablation procedures, but each ablation must achieve its own endpoints, such as bidirectional block of linear damage, posterior wall isolation, etc. After completing the preset ablation steps, DCCV will be performed. If AF is terminated after or during ablation, it is also considered the endpoint of ablation in this group, but the preset ablation steps must be completed.

Interventions

AF-termination Group

Each center completes the ablation according to the above ablation procedure. The choice of ablation strategy is not restricted, but efforts should be made to achieve termination of AF during the ablation procedure. If cannot terminate AF for safety or other reasons involving difficulties to remap AFEGM or creating a complete conduction block despite the operator's best efforts, then direct current conversion (DCCV) was performed.

Intervention Type: PROCEDURE

Prespecified-ablation Group

Each center completes the prespecified ablation according to the above ablation procedure. Although there is no restriction on the choice of ablation strategy, Ablation must be performed following the PVI plus strategy, which can be combined with one or more additional ablation procedures, but each ablation must achieve its own endpoints, such as bidirectional block of linear damage, posterior wall isolation, etc. After completing the preset ablation steps, DCCV will be performed. If AF is terminated after or during ablation, it is also considered the endpoint of ablation in this group, but the preset ablation steps must be completed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. . Age 18-80 years old.

2. . Patients undergoing a first-time ablation procedure for PersAF.

3. . Diagnosed as persistent AF according to the latest clinical guidelines.

4. . Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment.

5. . Patients must be able and willing to provide written informed consent to participate in this study.

Exclusion Criteria

1. . Uncontrolled congestive heart failure;

2. . History of severe valve disease and/or prosthetic valve replacement;

3. . Myocardial infarction or stroke within 6 months;

4. . Severe congenital heart disease;

5. . EF <35%;

6. . Contrast agent allergy;

7. . The use of anticoagulant drugs is contraindicated;

8. . Severe lung disease;

9. . Left atrial thrombus confirmed by preoperative esophageal ultrasound;

10. . Contraindications for cardiac catheterization;

11. . Prior left atrial ablation (surgical or catheter);

12. . Have performed any cardiac surgery within 2 months;

13. . Poor general health;

14. . Life expectancy < 12 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mu Qin

Shanghai, , China

Shanghai Chest Hospital

Shanghai, , China

Countries

China

Other Identifiers

CAPT-AF

Identifier Type: -

Identifier Source: org_study_id