Heart rhythm fix may also repair leaky valve: scientists build prediction model
NCT ID NCT07096219
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at people with persistent atrial fibrillation (an irregular heartbeat) and moderate-to-severe functional mitral regurgitation (a leaky heart valve). Researchers want to see if a procedure called catheter ablation—which zaps abnormal heart tissue to restore normal rhythm—can improve the valve leakage. They will also build and test a model to predict which patients are most likely to benefit. The goal is to help doctors make better treatment decisions for this common heart condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- catheter ablation
- What this could lead to
- If successful, this could help doctors predict which patients with atrial fibrillation and mitral regurgitation will benefit most from catheter ablation, enabling more personalized treatment decisions.
- What could go wrong
- This is an observational study, not a treatment trial. The predictive model may not be accurate enough for widespread use, and individual results can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 556 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with moderate-to-severe functional mitral regurgitation (FMR) and persistent atrial fibrillation undergoing catheter ablation
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18-75 years 2. 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+) 3. Persistent atrial fibrillation (AF) with successful catheter ablation 4. Signed informed consent with commitment to regular follow-up for ≥1 year Exclusion Criteria: 1. Acute or chronic degenerative mitral regurgitation (DMR) from any etiology 2. Paroxysmal or permanent atrial fibrillation 3. Planned repeat ablation for AF recurrence 4. Concomitant moderate/severe valvular disease (e.g., mitral stenosis, aortic stenosis/regurgitation, pulmonary stenosis/regurgitation) 5. Prior valvular surgery/intervention 6. History of open-heart surgery 7. Severe pulmonary hypertension (PASP \>70 mmHg) refractory to medical therapy 8. Left atrial diameter ≥60 mm (diastolic phase) on echocardiography 9. Uncontrolled hyperthyroidism 10. Intracardiac mass/thrombus/vegetation 11. Significant shunts (ASD/VSD/PDA) 12. Hypertrophic obstructive cardiomyopathy 13. Active severe infection/sepsis (including infective endocarditis) 14. Scheduled CRT/CRT-D/CCM implantation 15. Untreated critical CAD (e.g., ≥70% stenosis in proximal/mid LAD/LCX/RCA requiring revascularization) or concomitant major cardiovascular surgery needs 16. End-stage heart failure (ACC/AHA Stage D) requiring mechanical support/transplant listing 17. Severe hepatic dysfunction (acute liver failure/decompensated cirrhosis, Child-Pugh C) 18. Severe renal impairment (CKD 5: eGFR\<15 mL/min or dialysis) 19. Hemodynamic instability (SBP\<90 mmHg/MAP\<70 mmHg with hypoperfusion \[urine output\<30 mL/h\]) 20. Contraindications to antithrombotics: Active bleeding (GI/intracranial/visceral), bleeding disorders (hemophilia/ITP/leukemia etc.), severe hematologic abnormalities (platelets\<20×10⁹/L, spontaneous INR\>3) 21. Uncontrolled autoimmune/connective tissue disease 22. Acute MI within 4 weeks 23. Stroke within 30 days 24. Acute peptic ulcer/upper GI bleeding within 3 months 25. Pregnancy/lactation 26. Declined informed consent 27. Life expectancy \<1 year 28. Poor compliance (anticipated inability to complete follow-up) 29. Concurrent participation in conflicting clinical trials 30. Other investigator-determined exclusions.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shantou Central Hospital
Shantou, China
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Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a tiny implant fix a leaky heart valve without open surgery?
- New catheter procedure tightens leaky heart valves without surgery
- New study aims to uncover why some heart valves leak in AFib patients
- Heart failure drug combo may improve valve function
- New heart valve fix device takes on market leader in major trial
- MRI scans may predict who benefits from MitraClip heart valve repair