Persistent Atrial FibrillationPRAISENCT06791629
Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation
A study testing Pulsed Field Ablation and Radiofrequency Ablation in people with Persistent Atrial Fibrillation and Radiofrequency Catheter Ablation, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
This clinical trial aims to compare the efficacy and safety of pulsed field ablation and radiofrequency ablation to treat persistent atrial fibrillation in adults. Participants will: Undergo pulsed field ablation or radiofrequency ablation. Keep follow-up for at least 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation, Radiofrequency Catheter Ablation, Pulsed Field Ablation
- What is being tested?
- Pulsed Field Ablation and Radiofrequency Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to 15 Feb 2027
- 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
- 18-80 years
- Patients with non-valvular persistent atrial fibrillation undergoing their first catheter ablation (AF duration: 3 months to 3 years)
- Left atrial diameter on parasternal long-axis view of echocardiogram < 50 mm
- Agree to be randomly assigned to the ablation strategy and able to follow up
Who cannot join
- Atrial fibrillation due to reversible causes
- LVEF < 30%
- Severe congenital heart disease
- Severe liver or kidney dysfunction (eGFR < 15, Child-Pugh grade 3), or history of dialysis
- History of cardiac surgery, such as coronary artery bypass grafting, mechanical valve or prosthetic valve replacement
- History of pacemaker implantation, left atrial appendage closure, or patent foramen ovale closure
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- Contraindications to oral anticoagulation
- Contraindications to right or left heart catheterization
- Pregnancy
- Life expectancy < 1 year (e.g., advanced malignancy, end-stage renal disease)
- Currently enrolled in another trial evaluating medical devices or drugs
- Other situations where the investigator determines the subject is unsuitable for 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
Beijing Anzhen Hospital, Capital Medical University
Beijing
Deyong Long, +86 13522958166, dragon2008@vip.sina.com
About this study
Official title: Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation: A Randomized, Open-label, Non-inferior Study
This clinical trial aims to compare the efficacy and safety of pulsed field ablation and radiofrequency ablation to treat persistent atrial fibrillation in adults.
Participants will:
Undergo pulsed field ablation or radiofrequency ablation. Keep follow-up for at least 12 months.
Read the detailed description
Traditional treatment options for persistent atrial fibrillation (PeAF) include pharmacological management, electrical cardioversion, and catheter ablation. Pulmonary vein isolation (PVI) has become the cornerstone of ablation therapy and has been shown to be effective in clinical practice. However, its efficacy is relatively limited in patients with persistent AF compared with those with paroxysmal AF, and many patients still experience recurrence after treatment.
In recent years, linear ablation strategies based on alcohol ablation have been shown to improve the one-year maintenance of sinus rhythm in patients with PeAF. Traditional radiofrequency ablation (RF) has demonstrated good outcomes but still has certain limitations when dealing with PeAF. In several clinical studies, pulsed field ablation (PFA), an emerging and innovative technique, has shown non-inferiority in treating paroxysmal AF. Furthermore, PFA has also demonstrated significant efficacy in linear ablation sites such as the mitral isthmus line, posterior left atrial wall, and tricuspid isthmus line, highlighting its potential in treating PeAF. This study aims to compare the safety and efficacy of PFA and radiofrequency ablation (RF) in the treatment of PeAF through a multi-center, prospective, randomized, open-label, non-inferiority clinical trial, to provide a safer and more effective treatment option for clinical practice.
- Being tested
- Pulsed Field Ablation, Radiofrequency Ablation
- Keywords
- persistent atrial fibrillation, Radiofrequency Catheter Ablation, pulsed field ablation
- 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 AblationDevice
Patients will be treated with pulsed field ablation for atrial fibrillation.
Radiofrequency AblationDevice
Patients will be treated with radiofrequency ablation for atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency Ablation | Active comparator | Not described Receives: Device: Radiofrequency Ablation |
| Pulsed Field Ablation | Experimental | Not described Receives: Device: Pulsed Field Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from any documented atrial arrhythmia lasting for >30s in the absence of antiarrhythmic therapy in 12 months after the index ablation procedure (excluding a blanking period of 3 months)
Measured: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Secondary outcomes (7)
Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure
Measured: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Freedom from any documented atrial fibrillation lasting for >30s in 12 months after the index ablation procedure (excluding a blanking period of 3 months)
Measured: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Freedom from any documented atrial tachycardia and atrial flutter episodes in 12 months after the index ablation procedure
Measured: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Freedom from any documented atrial arrhythmia in the absence of antiarrhythmic therapy in 12 months after multiple ablation procedure (excluding a blanking period of 3 months)
Measured: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
The atrial fibrillation burden (percentage of time) monitored over 12 months
Measured: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Cardiovascular-related hospitalizations in 12 months after the index ablation procedure
Measured: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Perioperative complications in 30 days after the index ablation procedure
Cardiac tamponade or perforation, permanent phrenic nerve palsy, acute coronary artery occlusion, stroke/thromboembolism/transient ischemic attack, pulmonary vein stenosis, left atrial-esophageal fistula, vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula), coronary artery spasm, renal failure due to hemolysis, death, and other treatment-related complications requiring intervention or prolonging hospitalization.
Measured: From the end of the ablation to the 30 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start15 Feb 2025 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791629
- Sponsor's protocol ID
- 2025-PeAF ablation
- Acronym
- PRAISE
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation: A Randomized, Open-label, Non-inferior Study
- ClinicalTrials.gov ID
- NCT06791629
- Acronym / sponsor ID
- PRAISE / 2025-PeAF ablation
- Keywords
- persistent atrial fibrillation, Radiofrequency Catheter Ablation, pulsed field ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 24 Jan 2025 (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.
This clinical trial aims to compare the efficacy and safety of pulsed field ablation and radiofrequency ablation to treat persistent atrial fibrillation in adults.
Participants will:
Undergo pulsed field ablation or radiofrequency ablation. Keep follow-up for at least 12 months.
Detailed description
Traditional treatment options for persistent atrial fibrillation (PeAF) include pharmacological management, electrical cardioversion, and catheter ablation. Pulmonary vein isolation (PVI) has become the cornerstone of ablation therapy and has been shown to be effective in clinical practice. However, its efficacy is relatively limited in patients with persistent AF compared with those with paroxysmal AF, and many patients still experience recurrence after treatment.
In recent years, linear ablation strategies based on alcohol ablation have been shown to improve the one-year maintenance of sinus rhythm in patients with PeAF. Traditional radiofrequency ablation (RF) has demonstrated good outcomes but still has certain limitations when dealing with PeAF. In several clinical studies, pulsed field ablation (PFA), an emerging and innovative technique, has shown non-inferiority in treating paroxysmal AF. Furthermore, PFA has also demonstrated significant efficacy in linear ablation sites such as the mitral isthmus line, posterior left atrial wall, and tricuspid isthmus line, highlighting its potential in treating PeAF. This study aims to compare the safety and efficacy of PFA and radiofrequency ablation (RF) in the treatment of PeAF through a multi-center, prospective, randomized, open-label, non-inferiority clinical trial, to provide a safer and more effective treatment option for clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation | Active comparator | Device: Radiofrequency Ablation |
| Pulsed Field Ablation | Experimental | Device: Pulsed Field Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-80 years
- Patients with non-valvular persistent atrial fibrillation undergoing their first catheter ablation (AF duration: 3 months to 3 years)
- Left atrial diameter on parasternal long-axis view of echocardiogram < 50 mm
- Agree to be randomly assigned to the ablation strategy and able to follow up
Key exclusion criteria (12 listed)
- Atrial fibrillation due to reversible causes
- LVEF < 30%
- Severe congenital heart disease
- Severe liver or kidney dysfunction (eGFR < 15, Child-Pugh grade 3), or history of dialysis
- History of cardiac surgery, such as coronary artery bypass grafting, mechanical valve or prosthetic valve replacement
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 AblationPatients will be treated with pulsed field ablation for atrial fibrillation. | Device | Pulsed Field Ablation |
| Radiofrequency AblationPatients will be treated with radiofrequency ablation for atrial fibrillation. | Device | Radiofrequency Ablation |
Primary outcome
Freedom from any documented atrial arrhythmia lasting for >30s in the absence of antiarrhythmic therapy in 12 months after the index ablation procedure (excluding a blanking period of 3 months)
Time frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
7 secondary outcomes
Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure
Time frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Freedom from any documented atrial fibrillation lasting for >30s in 12 months after the index ablation procedure (excluding a blanking period of 3 months)
Time frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Freedom from any documented atrial tachycardia and atrial flutter episodes in 12 months after the index ablation procedure
Time frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Freedom from any documented atrial arrhythmia in the absence of antiarrhythmic therapy in 12 months after multiple ablation procedure (excluding a blanking period of 3 months)
Time frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
The atrial fibrillation burden (percentage of time) monitored over 12 months
Time frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Cardiovascular-related hospitalizations in 12 months after the index ablation procedure
Time frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up
Perioperative complications in 30 days after the index ablation procedure
Time frame: From the end of the ablation to the 30 days follow-up
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 24 Jan 2025.
- Individual participant dataSharing planned: No
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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 and Radiofrequency Ablation in people with Persistent Atrial Fibrillation and Radiofrequency Catheter Ablation, run by Beijing Anzhen Hospital 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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 24 Jan 2025. 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 Deyong Long (+86 135 2295 8166, dragon2008@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from any documented atrial arrhythmia lasting for >30s in the absence of antiarrhythmic therapy in 12 months after the index ablation procedure (excluding a blanking period of 3 months) (time frame: From the end of the 3-month blanking period post-ablation to the 12-month follow-up). 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 24 Jan 2025.