A Randomized Controlled Trial of Pulsed Field Ablation for Atrial Fibrillation (POWER-AF)

NCT07601763 | Recruiting DMC FDA Device

• 1 other identifier: 2024-2569
• Study Type: interventional
• Target: 1,574
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial fibrillation within 12 months after ablation

  Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds after the post-ablation blanking period, documented by 12-lead electrocardiogram, Holter monitoring, event recorder, or other rhythm monitoring methods.

  12 months after ablation

Secondary Outcomes (5)

• Change in atrial fibrillation burden from baseline to 12 months after ablation

  Baseline and 12 months after ablation

• Change in left ventricular ejection fraction from baseline to 12 months after ablation

  Baseline and 12 months after ablation

• Change in 36-Item Short Form Health Survey physical component summary score from baseline to 12 months after ablation

  Baseline and 12 months after ablation

• All-cause mortality within 12 months after ablation

  12 months after ablation

• Change in 36-Item Short Form Health Survey mental component summary score from baseline to 12 months after ablation

  Baseline and 12 months after ablation

Study Arms (2)

Pulsed Field Ablation Arm

EXPERIMENTAL

Procedure: Pulsed field ablation; Device: Pulsed field ablation system

Radiofrequency Ablation Arm

ACTIVE COMPARATOR

Procedure: Radiofrequency ablation alone

Interventions

Pulsed field ablation PROCEDURE

Left atrial electrical anatomical mapping modeling was performed using a high-density mapping catheter, and ablation was carried out using a pulsed field catheter. For patients with paroxysmal atrial fibrillation, bilateral large loop pulmonary vein isolation combined with left posterior atrial wall ablation is performed. For patients with persistent atrial fibrillation, bilateral large loop pulmonary vein isolation, left posterior atrial wall ablation, and mitral valve isthmus ablation are performed. For patients with atrial fibrillation rhythm after ablation, intravenous ibutilide/electrical cardioversion was used for conversion, and the specific conversion strategy was consistent with that of the radiofrequency ablation group.

Pulsed Field Ablation Arm

Radiofrequency ablation alone PROCEDURE

Radiofrequency ablation will be performed using a saline perfusion catheter, and the ablation catheter was empirically selected by the surgeon. For patients with paroxysmal atrial fibrillation, circumferential pulmonary vein isolation is performed. For patients with persistent atrial fibrillation, circumferential pulmonary vein isolation combined with individualized linear ablation is performed. For those whose ablation of all the established routes has been completed but whose sinus rhythm has not been restored, intravenous ibulide is used for drug cardioversion. If the drug fails to counteract, perform two-phase alternating current cardioversion. Cardioversion can be repeated at most twice.

Radiofrequency Ablation Arm

Pulsed field ablation system DEVICE

Pulsed field ablation will be performed using a pulsed field ablation system for pulmonary vein isolation and additional ablation as clinically indicated.

Pulsed Field Ablation Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

National Cardiovascular Diseases Center, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Yan Yao

CONTACT

010-88392405; ianyao@263.net.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 22, 2026
• Study Start: April 16, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-04

Locations

CN (1)