NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF)
| NCT ID | NCT07601763 |
| Status | Recruiting |
| Phase | — |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,574 participants |
| Start Date | 2025-04-16 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,574 participants in total. It began in 2025-04-16 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07601763 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07601763 currently recruiting?
Yes, NCT07601763 is actively recruiting participants. Contact the research team at ianyao@263.net.cn for enrollment information.
Where is the NCT07601763 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07601763 clinical trial?
NCT07601763 is sponsored by China National Center for Cardiovascular Diseases. The trial plans to enroll 1,574 participants.
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