PerAF: AF Termination vs Prespecified Ablation

NCT ID: NCT06837441

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-06-30

Brief Summary

The design of this study is an intervention, randomized, controlled study and contains two randomized groups：（1）AF-termination group；（2）Prespecified-ablation group.

Conditions

Persistent Atrial Fibrillation

Study Design

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

Study Groups

AF-termination group

Group Type: EXPERIMENTAL

Atrial Fibrillation Termination

Intervention Type: PROCEDURE

Pursuing Atrial Fibrillation Termination as a Procedural Endpoint

Prespecified-ablation group

Group Type: SHAM_COMPARATOR

Prespecified Ablation

Intervention Type: PROCEDURE

Prespecified Ablation Strategy Followed by Cardioversion

Interventions

Atrial Fibrillation Termination

Pursuing Atrial Fibrillation Termination as a Procedural Endpoint

Intervention Type: PROCEDURE

Prespecified Ablation

Prespecified Ablation Strategy Followed by Cardioversion

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. aged between 18 and 80 years old;

2. Patients undergoing a first-time ablation procedure for PersAF, and in spontaneous AF at the beginning of the procedure;

3. Diagnosed as persistent AF according to the latest clinical guidelines，with atrial fibrillation lasting for at least one month;

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;

6. Patients must be willing and able to comply with all study follow- up requirements.

Exclusion Criteria

1. .Uncontrolled congestive heart failure, EF <35%;

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. . Left atrial diameter ≥60mm;

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, including factors such as physical inability to tolerate ablation or unstable disease conditions.-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Shanghai Yangpu Central Hospital

UNKNOWN

Sponsor Role: collaborator

Jinshan Hospital Affiliated to Fudan University

UNKNOWN

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu Liu

Doctor Liu

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Chest Hospital

Shanghai, , China

Countries

China

Other Identifiers

TPAF

Identifier Type: -

Identifier Source: org_study_id