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

Official title

Pulsed Field Ablation for Atrial Fibrillation Including Posterior Wall and Linear Ablation: A Randomized Controlled Trial of Safety and Efficacy (POWER-AF)

Overview

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.

Interventions

• Procedure Pulsed field ablation
  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 perf
• Procedure Radiofrequency ablation alone
  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
• Device Pulsed field ablation system
  Pulsed field ablation will be performed using a pulsed field ablation system for pulmonary vein isolation and additional ablation as clinically indicated.

Primary outcome measures

• Recurrence of atrial fibrillation within 12 months after ablation [Time frame: 12 months after ablation]

Secondary outcome measures (5)

• Change in atrial fibrillation burden from baseline to 12 months after ablation [Time frame: Baseline and 12 months after ablation]
• Change in left ventricular ejection fraction from baseline to 12 months after ablation [Time frame: 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 [Time frame: Baseline and 12 months after ablation]
• All-cause mortality within 12 months after ablation [Time frame: 12 months after ablation]
• Change in 36-Item Short Form Health Survey mental component summary score from baseline to 12 months after ablation [Time frame: Baseline and 12 months after ablation]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• National Cardiovascular Diseases Center, Fuwai Hospital — Beijing

Identifiers

NCT: NCT07601763 · 2024-2569

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗