Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF)

National Center for Cardiovascular Diseases

Status: Enrolling

Conditions: Pulsed Field Ablation; Atrial Fibrillation Recurrent; Atrial Fibrillation (AF); Atrial Fibrillation Ablation; Radiofrequency Catheter Ablation

Treatments: Procedure: Radiofrequency ablation alone; Procedure: Pulsed field ablation; Device: Pulsed field ablation system

Study type: Interventional

Funder types: Other

Identifiers

NCT07601763

2024-2569

Details and patient eligibility

About

Atrial fibrillation (AF) is one of the most common arrhythmias in clinical practice. As of 2019, there were approximately 59.7 million patients with AF worldwide, including atrial flutter (AF). Atrial fibrillation can significantly increase the risks of stroke, thromboembolism and heart failure in patients, seriously affecting their quality of life.

Catheter ablation is the main means for rhythm control in patients with atrial fibrillation. A large number of clinical studies have confirmed the effectiveness and safety of catheter ablation for atrial fibrillation. It is significantly superior to drug treatment in maintaining sinus rhythm and can significantly improve symptoms and quality of life.

Pulsed electric field ablation (PFA) is a novel ablation method that utilizes pulsed electric fields as energy. It uses multiple short-duration and high-voltage electrical pulses to release ablation energy, selectively causing myocardial cells to rupture and die. However, it has no obvious damaging effect on blood vessels, nerves, and tissues around the heart, such as the lungs, esophagus, and phrenic nerve.

This trial was designed based on the advantage of the characteristic that PFA does not damage the esophagus, confining the damage to the posterior half of the left atrium and the circumferential isthmus of the mitral valve. While improving the ablation success rate, it is possible to protect the function of the left atrium. This study aims to verify the superiority of the new rhythm control strategy in a large-scale population by launching a prospective randomized controlled trial.

Enrollment: 1,574 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Atrial fibrillation patients who will accept catheter ablation.
2. Age ≥ 18.
3. Be capable of understanding and signing the informed consent form.

Exclusion criteria

1. Have contraindications for catheter ablation (such as atrial thrombosis, decompensated heart failure, etc.)
2. Have accepted catheter ablation before.
3. Myocardial infarction, or any cardiac interventional/surgery has been performed within 3 months.
4. Had a stroke or transient ischemic attack within 6 months.
5. Allergy to iodine contrast agents.
6. Participate in clinical trials related to other drugs or devices.
7. Pregnant women, lactating women, or women with plans to become pregnant shortly.
8. Active stage of infection.
9. Secondary atrial fibrillation, such as combined with rheumatic heart disease, hypertrophic cardiomyopathy, etc.
10. Patients who do not agree to be enrolled or are unable to cooperate to complete the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,574 participants in 2 patient groups

Pulsed Field Ablation Arm

Experimental group

Treatment:

Device: Pulsed field ablation system

Procedure: Pulsed field ablation

Radiofrequency Ablation Arm

Active Comparator group

Treatment:

Procedure: Radiofrequency ablation alone