Atrial Fibrillation (AF)NCT07518966
Association Between Early Recurrence and Long-Term Recurrence After Pulsed Field Ablation for Atrial Fibrillation: Prospective Real-World Evidence From China
An observational study of Atrial Fibrillation (AF), run by West China Hospital at 1 site in China.
Trial summary
The goal of this observational study is to analyze the predictive value of early recurrence within different time windows for late recurrence, ultimately providing evidence-based support for defining the blanking period after pulsed field ablation and stratifying recurrence risk, with the goal of transforming clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- pulsed field ablation
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2025to 30 Jun 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: Consecutively selected patients with atrial fibrillation who underwent pulsed field ablation (PFA) in the Department of Cardiology at West China Hospital of Sichuan University from June 2025 to June 2026. Patients were screened strictly in accordance with the inclusion and exclusion criteria to enroll eligible participants as study subjects.
Who may be able to join
- Patients aged ≥18 years
- Study participants diagnosed with atrial fibrillation (AF) and scheduled to undergo pulsed field ablation
- Study participants undergoing their first ablation procedure for AF
Who cannot join
- Study participants with any known contraindications to the pulsed field ablation system, anticoagulation therapy, use of contrast agents, or atrial fibrillation ablation
- Those who have previously undergone atrial fibrillation ablation, or have severe mitral stenosis, valve replacement, or various cardiac surgeries.
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
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Bangjiaxin Ren MD, +86-18983234883, rbcqmu189@126.com
About this study
The goal of this observational study is to analyze the predictive value of early recurrence within different time windows for late recurrence, ultimately providing evidence-based support for defining the blanking period after pulsed field ablation and stratifying recurrence risk, with the goal of transforming clinical management strategies following pulsed field ablation. The main questions it aims to answer are:
- Employ big data analysis methods to develop a risk stratification tool for atrial fibrillation;
- Identify high-risk prognostic indicators for atrial fibrillation and establish early assessment models for short-term and long-term prognosis.
Participants will undergo pulsed field ablation for the treatment of atrial fibrillation and will receive structured follow-ups at 1, 3, 6, and 12 months post-ablation. At each follow-up, a 24-hour Holter monitor will be performed to systematically assess the recurrence of atrial arrhythmias and the atrial arrhythmia burden.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- 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 ablationProcedure or surgery
The patient underwent the ablation procedure using the pentaspline pulsed field ablation system.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed field ablation group | Not described Receives: Procedure: pulsed field ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial arrhythmias
Including atrial fibrillation, atrial flutter, and atrial tachycardia, recorded as ≥10 seconds on a 12-lead electrocardiogram or ≥30 seconds on ambulatory electrocardiography (including single-lead patch devices).
Measured: from 3 months to 12 months post-ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start16 Jun 2025
- Primary completion16 Jun 2026 (estimated)
- Study completion30 Jun 2027 (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 West China 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bangjiaxin Ren, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518966
- Sponsor's protocol ID
- 2022(302)
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Early Recurrence and Long-Term Recurrence After Pulsed Field Ablation for Atrial Fibrillation: Prospective Real-World Evidence From China
- ClinicalTrials.gov ID
- NCT07518966
- Acronym / sponsor ID
- 2022(302)
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 16 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Apr 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.
The goal of this observational study is to analyze the predictive value of early recurrence within different time windows for late recurrence, ultimately providing evidence-based support for defining the blanking period after pulsed field ablation and stratifying recurrence risk, with the goal of transforming clinical management strategies following pulsed field ablation. The main questions it aims to answer are:
- Employ big data analysis methods to develop a risk stratification tool for atrial fibrillation;
- Identify high-risk prognostic indicators for atrial fibrillation and establish early assessment models for short-term and long-term prognosis.
Participants will undergo pulsed field ablation for the treatment of atrial fibrillation and will receive structured follow-ups at 1, 3, 6, and 12 months post-ablation. At each follow-up, a 24-hour Holter monitor will be performed to systematically assess the recurrence of atrial arrhythmias and the atrial arrhythmia burden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed field ablation group | – | Procedure: pulsed field ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutively selected patients with atrial fibrillation who underwent pulsed field ablation (PFA) in the Department of Cardiology at West China Hospital of Sichuan University from June 2025 to June 2026. Patients were screened strictly in accordance with the inclusion and exclusion criteria to enroll eligible participants as study subjects.
Key inclusion criteria (3 listed)
- Patients aged ≥18 years
- Study participants diagnosed with atrial fibrillation (AF) and scheduled to undergo pulsed field ablation
- Study participants undergoing their first ablation procedure for AF
Key exclusion criteria (2 listed)
- Study participants with any known contraindications to the pulsed field ablation system, anticoagulation therapy, use of contrast agents, or atrial fibrillation ablation
- Those who have previously undergone atrial fibrillation ablation, or have severe mitral stenosis, valve replacement, or various cardiac surgeries.
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 ablationThe patient underwent the ablation procedure using the pentaspline pulsed field ablation system. | Procedure or surgery | Pulsed field ablation group |
Primary outcome
Atrial arrhythmias
Time frame: from 3 months to 12 months post-ablation
Including atrial fibrillation, atrial flutter, and atrial tachycardia, recorded as ≥10 seconds on a 12-lead electrocardiogram or ≥30 seconds on ambulatory electrocardiography (including single-lead patch devices).
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 15 Apr 2026.
- 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?
An observational study of Atrial Fibrillation (AF), run by West China 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 3 inclusion and 2 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 15 Apr 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial arrhythmias (time frame: from 3 months to 12 months post-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 15 Apr 2026.