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

Shanghai Jiao Tong University

Status: Completed

Conditions: Atrial Fibrillation; Endpoint; Cathter Ablation

Treatments: Procedure: Prespecified-ablation Group; Procedure: AF-termination Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05921734

CAPT-AF

Details and patient eligibility

About

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).

Enrollment: 480 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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480 participants in 2 patient groups

AF-termination Group

Experimental group

Treatment:

Procedure: AF-termination Group

Prespecified-ablation Group

Active Comparator group

Treatment:

Procedure: Prespecified-ablation Group