Atrial Fibrillation Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Atrial fibrillation patients who will accept catheter ablation.

• Age ≥ 18.

• Be capable of understanding and signing the informed consent form.

Locations
Other Locations
China
National Cardiovascular Diseases Center, Fuwai Hospital
RECRUITING
Beijing
Contact Information
Primary
Yan Yao
ianyao@263.net.cn
010-88392405
Time Frame
Start Date: 2025-04-16
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 1574
Treatments
Experimental: Pulsed Field Ablation Arm
Active_comparator: Radiofrequency Ablation Arm
Sponsors
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov