Atrial FibrillationNCT05266144
Atrial Fibrillation Patients Treated With Catheter Ablation
An observational study of Atrial Fibrillation and Atrial Fibrillation Recurrent, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a single-center prospective observational cohort study of atrial fibrillation patients treated with radiofrequency ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Fibrillation Recurrent
- What is being tested?
- radiofrequency ablation
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2020to 31 Dec 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive atrial fibrillation patients, who underwent catheter ablation in Peking Union Medical College Hospital, were enrolled. All patients went through bilateral pulmonary vein isolation under general or local anesthesia, and were regularly followed up at 3-month and 1-year after ablation.
Who may be able to join
- Non-valvular atrial fibrillation, including paroxysmal atrial fibrillation and persistent atrial fibrillation
- 18-80 years old
- The anteroposterior diameter of the left atrium is less than 50mm via TTE
- Patient meets the intervention criteria for bilateral pulmonary vein isolation after evaluation by electrophysiological specialists
- Patient consents to ablation treatment
Who cannot join
- Intra-atrial thrombus detected by TEE
- Hyperthyroidism
- Previous radiofrequency ablation for atrial fibrillation
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Yongtai Liu, M.D., +86-1069155068, ataiever@163.com
Quan Fang, M.D., +86-1069155068, fangquanpumch@163.com
About this study
Official title: A Prospective Cohort Study of Atrial Fibrillation Patients Treated With Catheter Ablation
This is a single-center prospective observational cohort study of atrial fibrillation patients treated with radiofrequency ablation.
Read the detailed description
The effect of radiofrequency therapy on the life quality and atrial function of atrial fibrillation patients will be assessed, through the multidimensional analysis of baseline clinical data, serological indicators of atrial fibrosis, echocardiography, cardiac magnetic resonance imaging, atrial potential mapping, life quality, and long-term ECG monitoring within 1 week after radiofrequency ablation. A predictive model for atrial fibrillation recurrence after ablation will be established. Based on the cross-sectional analysis of baseline data, the relationship between non-invasive assessment of atrial fibrosis (imaging and serology), atrial electrical activity, and atrial function will be analyzed as well, and atrial fibrillation patients with ventricular fibrosis will be selected for gene sequencing to explore the existence of underlying cardiomyopathy and provide data for further research.
- Conditions
- Atrial Fibrillation, Atrial Fibrillation Recurrent
- Being tested
- radiofrequency 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.
radiofrequency ablationProcedure or surgery
Bilateral pulmonary vein isolation, a kind of radiofrequency ablation, is performed in atrial fibrillation patients for atrial arrhythmia therapy.
| Study group | Role | What they receive |
|---|---|---|
| atrial fibrillation | Atrial fibrillation patients who underwent radiofrequency ablation in Peking Union Medical College Hospital. Receives: Procedure: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence assessed by ECG, Holter reports and outpatient physicians
Recurrence includes atrial fibrillation and atrial flutter. Recurrence features including pattern, duration, burden, etc. will be recorded.
Measured: at 1-year follow-up after ablation
All-cause mortality assessed by telephone follow-up or medical records
Time and cause of death will be recorded.
Measured: at 1-year follow-up after ablation
Secondary outcomes (4)
Improvement in life quality assessed by QOLSF36 Questionnaire
Life quality will be assessed at baseline and 1-year FU. Improvement in life quality indicates that patients can benefit from the catheter ablation.
Measured: at 1-year follow-up after ablation
Improvement in left atrial function assessed by echocardiography
Left atrial function will be assessed at baseline and 1-year FU. Improvement in atrial function indicates that ablation can restore atrial function.
Measured: at 1-year follow-up after ablation
Embolic events assessed by physicians and further examinations like ultrasound, MRI
Embolism may be related to atrial fibrillation. Embolism will be assessed by physicians according to patients' symptoms and signs at clinic or by telephone. If a patient's clinical presentation indicates embolism, the patient will be further assessed by ultrasound, MRI, etc.
Measured: at 1-year follow-up after ablation
Hospitalization for heart failure, atrial fibrillation or atrial flutter
Postoperative hospitalization indicate worse prognosis.
Measured: at 1-year follow-up after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start4 Sep 2020
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quan Fang, M.D., Study chair, Peking Union Medical College HospitalYongtai Liu, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266144
- Sponsor's protocol ID
- PUMCH-AF
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2022
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lai J, Qin X, Zhang D, Wang J, Yu J, Sun K, Yang D, Fan J, Zhang L, Cheng Z, Cheng K, Gao P, Deng H, Fang L, Chen T, Fang Q, Liu Y. The diagnostic value of left atrial stiffness for heart failure with preserved ejection fraction in patients with paroxysmal atrial fibrillation. Echo Res Pract. 2026 Feb 23;13(1):6. doi: 10.1186/s44156-026-00107-5.
PubMed 41725017Sun K, Qin X, Zhang D, Fang F, Wan R, Wang J, Yu J, Lai J, Yang D, Fan J, Cheng Z, Cheng K, Gao P, Zhang L, Deng H, Fang Q, Chen T, Liu Y. HFpEF correlated with better improvement of left atrial function in post-ablation patients with paroxysmal atrial fibrillation. Int J Cardiovasc Imaging. 2025 Apr;41(4):721-732. doi: 10.1007/s10554-025-03359-0. Epub 2025 Mar 1.
PubMed 40025277
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Atrial Fibrillation Patients Treated With Catheter Ablation
- ClinicalTrials.gov ID
- NCT05266144
- Acronym / sponsor ID
- PUMCH-AF
- Conditions
- Atrial Fibrillation, Atrial Fibrillation Recurrent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Mar 2022 (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 is a single-center prospective observational cohort study of atrial fibrillation patients treated with radiofrequency ablation.
Detailed description
The effect of radiofrequency therapy on the life quality and atrial function of atrial fibrillation patients will be assessed, through the multidimensional analysis of baseline clinical data, serological indicators of atrial fibrosis, echocardiography, cardiac magnetic resonance imaging, atrial potential mapping, life quality, and long-term ECG monitoring within 1 week after radiofrequency ablation. A predictive model for atrial fibrillation recurrence after ablation will be established. Based on the cross-sectional analysis of baseline data, the relationship between non-invasive assessment of atrial fibrosis (imaging and serology), atrial electrical activity, and atrial function will be analyzed as well, and atrial fibrillation patients with ventricular fibrosis will be selected for gene sequencing to explore the existence of underlying cardiomyopathy and provide data for further research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| atrial fibrillation | – | Procedure: radiofrequency ablationAtrial fibrillation patients who underwent radiofrequency ablation in Peking Union Medical College Hospital. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive atrial fibrillation patients, who underwent catheter ablation in Peking Union Medical College Hospital, were enrolled. All patients went through bilateral pulmonary vein isolation under general or local anesthesia, and were regularly followed up at 3-month and 1-year after ablation.
Key inclusion criteria (5 listed)
- Non-valvular atrial fibrillation, including paroxysmal atrial fibrillation and persistent atrial fibrillation
- 18-80 years old
- The anteroposterior diameter of the left atrium is less than 50mm via TTE
- Patient meets the intervention criteria for bilateral pulmonary vein isolation after evaluation by electrophysiological specialists
- Patient consents to ablation treatment
Key exclusion criteria (3 listed)
- Intra-atrial thrombus detected by TEE
- Hyperthyroidism
- Previous radiofrequency ablation for atrial fibrillation
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 |
|---|---|---|
| radiofrequency ablationBilateral pulmonary vein isolation, a kind of radiofrequency ablation, is performed in atrial fibrillation patients for atrial arrhythmia therapy. | Procedure or surgery | atrial fibrillation |
Primary outcome
Recurrence assessed by ECG, Holter reports and outpatient physicians
Time frame: at 1-year follow-up after ablation
Recurrence includes atrial fibrillation and atrial flutter. Recurrence features including pattern, duration, burden, etc. will be recorded.
All-cause mortality assessed by telephone follow-up or medical records
Time frame: at 1-year follow-up after ablation
Time and cause of death will be recorded.
4 secondary outcomes
Improvement in life quality assessed by QOLSF36 Questionnaire
Time frame: at 1-year follow-up after ablation
Improvement in left atrial function assessed by echocardiography
Time frame: at 1-year follow-up after ablation
Embolic events assessed by physicians and further examinations like ultrasound, MRI
Time frame: at 1-year follow-up after ablation
Hospitalization for heart failure, atrial fibrillation or atrial flutter
Time frame: at 1-year follow-up 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 3 Nov 2026.
- Derived from this study: PubMed 41725017Lai J, Qin X, Zhang D, Wang J, Yu J, Sun K, Yang D, Fan J, Zhang L, Cheng Z, Cheng K, Gao P, Deng H, Fang L, Chen T, Fang Q, Liu Y. The diagnostic value of left atrial stiffness for heart failure with preserved ejection fraction in patients with paroxysmal atrial fibrillation. Echo Res Pract. 2026 Feb 23;13(1):6. doi: 10.1186/s44156-026-00107-5.
- Derived from this study: PubMed 40025277Sun K, Qin X, Zhang D, Fang F, Wan R, Wang J, Yu J, Lai J, Yang D, Fan J, Cheng Z, Cheng K, Gao P, Zhang L, Deng H, Fang Q, Chen T, Liu Y. HFpEF correlated with better improvement of left atrial function in post-ablation patients with paroxysmal atrial fibrillation. Int J Cardiovasc Imaging. 2025 Apr;41(4):721-732. doi: 10.1007/s10554-025-03359-0. Epub 2025 Mar 1.
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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.
Quan Fang, M.D. study chair
Peking Union Medical College Hospital
Yongtai Liu, M.D. principal investigator
Peking Union Medical College Hospital
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 and Atrial Fibrillation Recurrent, run by Peking Union Medical College 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 5 inclusion and 3 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 3 Nov 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 Yongtai Liu, M.D. (+86-1069155068, ataiever@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence assessed by ECG, Holter reports and outpatient physicians (time frame: at 1-year follow-up after ablation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05266144, which also lists 2 linked publications.
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 3 Nov 2026.