PerAF: AF Termination vs Prespecified Ablation

Not Applicable

Completed

• Conditions: Persistent Atrial Fibrillation

• Registration Number: NCT06837441
• Lead Sponsor: Shanghai Chest Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-01
• Primary Completion: 2023-06-30
• Study Completion: 2024-06-30
• Study First Submitted: 2025-02-16
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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.-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom from any documented atrial arrhythmia - atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) - of more than 30 seconds, excluding the initial 3 months blanking period, at a minimum of 12 months follow up after a single ablat	12 months

Secondary Outcome Measures

Name	Time	Method
Freedom from AF after a single procedure without anti-arrhythmic medications (excludes the blanking period) at 12 months；	12 months
Freedom from AF/AT/AFL after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months	12 months
Freedom from AF after a single procedure with/without anti-arrhythmic medications (excludes the blanking period) at 12 months	12 months
Freedom from any AT episodes lasting more than 30 seconds after the blanking period without AADs after a single procedure	12 months
Incidence of periprocedural adverse events.	12 months

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China