Atrial Fibrillation (AF)POWER-AFNCT07601763
Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF)
A study testing Pulsed field ablation, Radiofrequency ablation alone and Pulsed field ablation system in people with Atrial Fibrillation (AF) and Atrial Fibrillation Ablation, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Fibrillation Ablation, Atrial Fibrillation Recurrent
- What is being tested?
- Pulsed field ablation, Radiofrequency ablation alone and Pulsed field ablation system
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,574 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Atrial fibrillation patients who will accept catheter ablation.
- Age ≥ 18.
- Be capable of understanding and signing the informed consent form.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cardiovascular Diseases Center, Fuwai Hospital
Beijing, Beijing Municipality, 100037
Yao Yan, 010-88392405, ianyao@263.net.cn
About this study
Official title: Pulsed Field Ablation for Atrial Fibrillation Including Posterior Wall and Linear Ablation: A Randomized Controlled Trial of Safety and Efficacy (POWER-AF)
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.
Read more
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
- Being tested
- Pulsed field ablation, Radiofrequency ablation alone, Pulsed field ablation system
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed field ablationProcedure or surgery
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.
Radiofrequency ablation aloneProcedure or surgery
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.
Pulsed field ablation systemDevice
Pulsed field ablation will be performed using a pulsed field ablation system for pulmonary vein isolation and additional ablation as clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Field Ablation Arm | Experimental | Not described Receives: Procedure: Pulsed field ablation; Device: Pulsed field ablation system |
| Radiofrequency Ablation Arm | Active comparator | Not described Receives: Procedure: Radiofrequency ablation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after ablation
Secondary outcomes (5)
Change in atrial fibrillation burden from baseline to 12 months after ablation
Change in atrial fibrillation burden among participants with paroxysmal atrial fibrillation. Atrial fibrillation burden is defined as the percentage of monitored time spent in atrial fibrillation during rhythm monitoring.
Measured: Baseline and 12 months after ablation
Change in left ventricular ejection fraction from baseline to 12 months after ablation
Change in left ventricular ejection fraction measured by echocardiography. Unit of Measure: Percentage points
Measured: 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
Change in quality of life assessed using the physical component summary score of the 36-Item Short Form Health Survey. Scores range from 0 to 100, with higher scores indicating better physical health status.
Measured: Baseline and 12 months after ablation
All-cause mortality within 12 months after ablation
Death from any cause during the 12-month follow-up period after ablation. Unit of Measure: Number or percentage of participants
Measured: 12 months after ablation
Change in 36-Item Short Form Health Survey mental component summary score from baseline to 12 months after ablation
Change in quality of life assessed using the mental component summary score of the 36-Item Short Form Health Survey. Scores range from 0 to 100, with higher scores indicating better mental health status.
Measured: Baseline and 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start16 Apr 2025
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,574 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601763
- Sponsor's protocol ID
- 2024-2569
- Acronym
- POWER-AF
- Status last verified
- Apr 2026
- First submitted
- 8 May 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Field Ablation for Atrial Fibrillation Including Posterior Wall and Linear Ablation: A Randomized Controlled Trial of Safety and Efficacy (POWER-AF)
- ClinicalTrials.gov ID
- NCT07601763
- Acronym / sponsor ID
- POWER-AF / 2024-2569
- Conditions
- Atrial Fibrillation (AF), Atrial Fibrillation Ablation, Atrial Fibrillation Recurrent, Pulsed Field Ablation, Radiofrequency Catheter Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,574 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Field Ablation Arm | Experimental | Procedure: Pulsed field ablation, Device: Pulsed field ablation system |
| Radiofrequency Ablation Arm | Active comparator | Procedure: Radiofrequency ablation alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Atrial fibrillation patients who will accept catheter ablation.
- Age ≥ 18.
- Be capable of understanding and signing the informed consent form.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed field ablationLeft 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. | Procedure or surgery | Pulsed Field Ablation Arm |
| Radiofrequency ablation aloneRadiofrequency 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. | Procedure or surgery | Radiofrequency Ablation Arm |
| Pulsed field ablation systemPulsed field ablation will be performed using a pulsed field ablation system for pulmonary vein isolation and additional ablation as clinically indicated. | Device | Pulsed Field Ablation Arm |
Primary outcome
Recurrence of atrial fibrillation within 12 months after ablation
Time frame: 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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
Related trials for Atrial Fibrillation (AF)
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
Recruiting
Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation
Atrial Fibrillation (AF)
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed field ablation, Radiofrequency ablation alone and Pulsed field ablation system in people with Atrial Fibrillation (AF) and Atrial Fibrillation Ablation, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Yao (010-88392405, ianyao@263.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of atrial fibrillation within 12 months after ablation (time frame: 12 months after ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.