AF Ablation Patients With Moderate+ FMR and Persistent AFNCT07096219
Catheter Ablation for Functional Mitral Regurgitation in Persistent Atrial Fibrillation: Development and Validation of a Predictive Model-A Multicenter Prospective Cohort Study
An observational study of AF Ablation Patients With Moderate+ FMR and Persistent AF, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites in China.
Trial summary
Mitral Regurgitation (MR) is the most prevalent type of valvular heart disease in clinical practice, with an average prevalence of approximately 1% in populations with moderate-to-severe or worse MR, which increases significantly with age. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- AF Ablation Patients With Moderate+ FMR and Persistent AF
- What is being tested?
- Catheter Ablation and ultrasonic cardiography (UCG)
- Type of treatment
- Surgery or procedure
- How many people
- 556 participants
- Where
- 2 sitesChina
- Study dates
- 31 Dec 2024to 30 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate-to-severe functional mitral regurgitation (FMR) and persistent atrial fibrillation undergoing catheter ablation
Who may be able to join
- Aged 18-75 years
- Diagnosis of functional mitral regurgitation (FMR) by transthoracic echocardiography (TTE) and/or transesophageal echocardiography (TEE) with combined qualitative and quantitative assessment, demonstrating moderate or worse regurgitation (≥ grade 2+)
- Persistent atrial fibrillation (AF) with successful catheter ablation
- Signed informed consent with commitment to regular follow-up for ≥1 year
Who cannot join
- Acute or chronic degenerative mitral regurgitation (DMR) from any etiology
- Paroxysmal or permanent atrial fibrillation
- Planned repeat ablation for AF recurrence
- Concomitant moderate/severe valvular disease (e.g., mitral stenosis, aortic stenosis/regurgitation, pulmonary stenosis/regurgitation)
- Prior valvular surgery/intervention
- History of open-heart surgery
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- Severe pulmonary hypertension (PASP >70 mmHg) refractory to medical therapy
- Left atrial diameter ≥60 mm (diastolic phase) on echocardiography
- Uncontrolled hyperthyroidism
- Intracardiac mass/thrombus/vegetation
- Significant shunts (ASD/VSD/PDA)
- Hypertrophic obstructive cardiomyopathy
- Active severe infection/sepsis (including infective endocarditis)
- Scheduled CRT/CRT-D/CCM implantation
- Untreated critical CAD (e.g., ≥70% stenosis in proximal/mid LAD/LCX/RCA requiring revascularization) or concomitant major cardiovascular surgery needs
- End-stage heart failure (ACC/AHA Stage D) requiring mechanical support/transplant listing
- Severe hepatic dysfunction (acute liver failure/decompensated cirrhosis, Child-Pugh C)
- Severe renal impairment (CKD 5: eGFR<15 mL/min or dialysis)
- Hemodynamic instability (SBP<90 mmHg/MAP<70 mmHg with hypoperfusion [urine output<30 mL/h])
- Contraindications to antithrombotics: Active bleeding (GI/intracranial/visceral), bleeding disorders (hemophilia/ITP/leukemia etc.), severe hematologic abnormalities (platelets<20×10⁹/L, spontaneous INR>3)
- Uncontrolled autoimmune/connective tissue disease
- Acute MI within 4 weeks
- Stroke within 30 days
- Acute peptic ulcer/upper GI bleeding within 3 months
- Pregnancy/lactation
- Declined informed consent
- Life expectancy <1 year
- Poor compliance (anticipated inability to complete follow-up)
- Concurrent participation in conflicting clinical trials
- Other investigator-determined exclusions.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Shantou Central Hospital
Shantou
About this study
Official title: The Improvement Effect of Catheter Ablation on Functional Mitral Regurgitation in Patients With Persistent Atrial Fibrillation and the Construction and Validation of a Predictive Model: A Multicenter Prospective Cohort Study
Mitral Regurgitation (MR) is the most prevalent type of valvular heart disease in clinical practice, with an average prevalence of approximately 1% in populations with moderate-to-severe or worse MR, which increases significantly with age. Functional MR (FMR) is one subtype of MR and can be further classified into atrial FMR, ventricular FMR, and mixed FMR based on its underlying mechanisms. Pathophysiologically, FMR is closely associated with atrial fibrillation (AF) and heart failure (HF). Studies suggest that catheter ablation for AF may improve FMR in some patients and reverse left atrial (LA) and left ventricular (LV) remodeling. However, there is currently a lack of precise and effective indicators or predictive models to determine the evolution of FMR after AF ablation in both domestic and international research.
This study aims to conduct a multicenter prospective cohort study, enrolling patients with moderate or worse FMR and persistent AF undergoing ablation. Using postoperative 3-month FMR improvement as the primary outcome, we will employ big data mining and multimodal analysis to construct a predictive model for FMR progression after AF ablation and validate it through prospective multicenter testing. The findings will provide a scientific basis for clinical decision-making and precision medicine in this patient population.
- Being tested
- Catheter Ablation, ultrasonic cardiography (UCG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter AblationProcedure or surgery
A minimally invasive procedure that delivers energy through catheters to destroy abnormal cardiac tissue causing arrhythmias.
ultrasonic cardiography (UCG)Diagnostic test
Trans-thoracic echocardiography (TTE) is performed in the resting position. Trans-esophageal echocardiography (TEE) is performed under surfa
| Study group | Role | What they receive |
|---|---|---|
| Catheter Ablation for Functional Mitral Regurgitation in Persistent Atrial Fibrillation | Not described Receives: Procedure: Catheter Ablation; Diagnostic Test: ultrasonic cardiography (UCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was MR improvement at 3 months post-procedure.
MR improvement was defined as a reduction in regurgitation severity by ≥1 grade on 3-month post-ablation transthoracic echocardiography (TTE) compared to baseline. Absence of improvement or worsening was categorized as non-improvement.
Measured: From the operation day to 3 months after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start31 Dec 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AF Ablation Patients With Moderate+ FMR and Persistent AFStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- 556 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shantou Central Hospital, Dongguan People's Hospital, Second Affiliated Hospital of Nanchang University, First Affiliated Hospital of Shantou University Medical College, West China Hospital, Zhongshan People's Hospital, Guangdong, China, Qingyuan People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Jiangmen Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, First Affiliated Hospital of Chongqing Medical University, Jiangxi Provincial People's Hopital, Guangdong Provincial People's Hospital, The University of Hong Kong-Shenzhen Hospital, First Affiliated Hospital of Xinjiang Medical University, Second Affiliated Hospital of Guangzhou Medical University, Second Xiangya Hospital of Central South University, Zhongnan Hospital, Ningbo Medical Center Lihuili Hospital, Sir Run Run Shaw Hospital, China-Japan Union Hospital, Jilin University, Xiangya Hospital of Central South University, Shanxi Cardiovascular Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Shenzhen People's Hospital, First Affiliated Hospital, Sun Yat-Sen University, Tongji Hospital, Nanfang Hospital, Southern Medical University, First People's Hospital of Foshan, Renmin Hospital of Wuhan University, Guizhou Provincial People's Hospital, The First Affiliated Hospital of Air Force Medical University, The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Dalian Medical University, Jiangsu Provincial People's Hospital, Meizhou People's Hospital, Yuebei People's Hospital, The Third Xiangya Hospital of Central South University, Third Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Wenzhou Medical University, Nanhai District People's Hospital
- Responsible party
- Principal investigator, Yangxin Chen, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Yangxin Chen, PhD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096219
- Sponsor's protocol ID
- SYSKY-2024-803-02
- Other IDs
- SYSKY-2024-803-01
- Status last verified
- Jun 2026
- First submitted
- 24 Jul 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improvement Effect of Catheter Ablation on Functional Mitral Regurgitation in Patients With Persistent Atrial Fibrillation and the Construction and Validation of a Predictive Model: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07096219
- Acronym / sponsor ID
- SYSKY-2024-803-02
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Shantou Central Hospital, Dongguan People's Hospital, Second Affiliated Hospital of Nanchang University, First Affiliated Hospital of Shantou University Medical College, West China Hospital, Zhongshan People's Hospital, Guangdong, China, Qingyuan People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Jiangmen Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, First Affiliated Hospital of Chongqing Medical University, Jiangxi Provincial People's Hopital, Guangdong Provincial People's Hospital, The University of Hong Kong-Shenzhen Hospital, First Affiliated Hospital of Xinjiang Medical University, Second Affiliated Hospital of Guangzhou Medical University, Second Xiangya Hospital of Central South University, Zhongnan Hospital, Ningbo Medical Center Lihuili Hospital, Sir Run Run Shaw Hospital, China-Japan Union Hospital, Jilin University, Xiangya Hospital of Central South University, Shanxi Cardiovascular Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Shenzhen People's Hospital, First Affiliated Hospital, Sun Yat-Sen University, Tongji Hospital, Nanfang Hospital, Southern Medical University, First People's Hospital of Foshan, Renmin Hospital of Wuhan University, Guizhou Provincial People's Hospital, The First Affiliated Hospital of Air Force Medical University, The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Dalian Medical University, Jiangsu Provincial People's Hospital, Meizhou People's Hospital, Yuebei People's Hospital, The Third Xiangya Hospital of Central South University, Third Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Wenzhou Medical University, Nanhai District People's Hospital
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 31 Jul 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.
Mitral Regurgitation (MR) is the most prevalent type of valvular heart disease in clinical practice, with an average prevalence of approximately 1% in populations with moderate-to-severe or worse MR, which increases significantly with age. Functional MR (FMR) is one subtype of MR and can be further classified into atrial FMR, ventricular FMR, and mixed FMR based on its underlying mechanisms. Pathophysiologically, FMR is closely associated with atrial fibrillation (AF) and heart failure (HF). Studies suggest that catheter ablation for AF may improve FMR in some patients and reverse left atrial (LA) and left ventricular (LV) remodeling. However, there is currently a lack of precise and effective indicators or predictive models to determine the evolution of FMR after AF ablation in both domestic and international research.
This study aims to conduct a multicenter prospective cohort study, enrolling patients with moderate or worse FMR and persistent AF undergoing ablation. Using postoperative 3-month FMR improvement as the primary outcome, we will employ big data mining and multimodal analysis to construct a predictive model for FMR progression after AF ablation and validate it through prospective multicenter testing. The findings will provide a scientific basis for clinical decision-making and precision medicine in this patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter Ablation for Functional Mitral Regurgitation in Persistent Atrial Fibrillation | – | Procedure: Catheter Ablation, Diagnostic Test: ultrasonic cardiography (UCG) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate-to-severe functional mitral regurgitation (FMR) and persistent atrial fibrillation undergoing catheter ablation
Key inclusion criteria (4 listed)
- Aged 18-75 years
- Diagnosis of functional mitral regurgitation (FMR) by transthoracic echocardiography (TTE) and/or transesophageal echocardiography (TEE) with combined qualitative and quantitative assessment, demonstrating moderate or worse regurgitation (≥ grade 2+)
- Persistent atrial fibrillation (AF) with successful catheter ablation
- Signed informed consent with commitment to regular follow-up for ≥1 year
Key exclusion criteria (30 listed)
- Acute or chronic degenerative mitral regurgitation (DMR) from any etiology
- Paroxysmal or permanent atrial fibrillation
- Planned repeat ablation for AF recurrence
- Concomitant moderate/severe valvular disease (e.g., mitral stenosis, aortic stenosis/regurgitation, pulmonary stenosis/regurgitation)
- Prior valvular surgery/intervention
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 |
|---|---|---|
| Catheter AblationA minimally invasive procedure that delivers energy through catheters to destroy abnormal cardiac tissue causing arrhythmias. | Procedure or surgery | Catheter Ablation for Functional Mitral Regurgitation in Persistent Atrial Fibrillation |
| ultrasonic cardiography (UCG)Trans-thoracic echocardiography (TTE) is performed in the resting position. Trans-esophageal echocardiography (TEE) is performed under surfa | Diagnostic test | Catheter Ablation for Functional Mitral Regurgitation in Persistent Atrial Fibrillation |
Primary outcome
The primary endpoint was MR improvement at 3 months post-procedure.
Time frame: From the operation day to 3 months after operation.
MR improvement was defined as a reduction in regurgitation severity by ≥1 grade on 3-month post-ablation transthoracic echocardiography (TTE) compared to baseline. Absence of improvement or worsening was categorized as non-improvement.
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 18 Jun 2026.
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.
Yangxin Chen, PhD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AF Ablation Patients With Moderate+ FMR and Persistent AF, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites 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 30 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: enrolling by invitation, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint was MR improvement at 3 months post-procedure. (time frame: From the operation day to 3 months after operation.). 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 18 Jun 2026.