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RecruitingNCT07414225STARUpdated Sep 11, 2026

Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation

An interventional study of Transcatheter Edge-to-Edge Repair and Guideline-Directed Medical Therapy (GDMT) for cardiovascular disease in Atrial Functional Mitral Regurgitation, sponsored by Beijing Anzhen Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 55 studies in Mitral Valve Insufficiency with a site in China — 42 open to participants now, 44 under way, none of them phase 3. Mitral Valve Insufficiency · China.

Planned enrollment
7th of 40
400 · median 127
Started
2026
with 6 others
No phase
36 of 55
29 open now
Primary completion
2030-02
later than 40 of 43 live
Registered
47th of 55
by date
Lead sponsor
4 of 55
Beijing Anzhen Hospital

Among the 55 studies in Mitral Valve Insufficiency with a site in China, this one is the 7th largest by planned enrollment of the 40 interventional ones, is one of 7 that started in 2026, is one of 36 with no phase, reaches primary completion later than 40 of the 43 other live ones, and was the 47th registered.

By phase

55 studies; the count open now beside each. This study's row is marked.

No phasethis study36 · 29 open
Observational15 · 10 open
Phase 44 · 3 open

By the year they started

First in 2012; this study’s year is marked. 7 started in 2026.

Size and results

Median enrollment 127 across the 40 interventional studies, 464 across the 15 observational. Of the 5 that completed or were terminated, 1 (20%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 55 studies in Mitral Valve Insufficiency with a site in China, or all of them as a file.
02

Study summary

This study is a prospective, randomized, parallel-control, open-label, multicenter clinical trial. Eligible subjects will be randomized in a 1:1 ratio to the Device group (Interventional group) or to no Device group (Control Group). The objective is to identify the safety and effectiveness of the TEER for the treatment of moderate-to-severe (3+) or severe (4+) atrial functional mitral regurgitation (aFMR) in patients who are symptomatic despite maximally tolerated guideline directed medical therapy.

Read the detailed description

Atrial functional mitral regurgitation (AFMR) is a complex cardiovascular condition typified by mitral regurgitation (MR), primarily due to atrial fibrillation-induced or diastolic dysfunction-induced left atrial enlargement, with mitral annular dilation and functional alterations of the mitral valve, rather than intrinsic valvular defects, resulting in regurgitation1. The reported prevalence of AFMR varies across studies, attributable to discrepancies in definitions, diagnostic techniques, research designs, and the specific populations investigated2-8. In a cohort study of hospitalized patients undergoing atrial fibrillation ablation, the prevalence of moderate or severe AFMR was 7%1. Conversely, in a community-based screening cohort of patients with moderate or severe MR, AFMR accounted for 27% of cases, marginally lower than the proportions of ventricular functional mitral regurgitation (VFMR, 38%) and primary mitral regurgitation (PMR, 32%)9. It can be anticipated that with the acceleration of aging in the global population, the proportion of AFMR may witness a considerable expansion in the future.

Compared with PMR, patients with AFMR frequently present with greater symptoms, diminished exercise tolerance, and heightened risk for hospitalization due to heart failure and increased mortality9,10, underscoring AFMR as a challenging therapeutic scenario. The conventional management strategies for mitral regurgitation have proven less effective in cases of AFMR2,11,12, due to its unique pathophysiological mechanisms, highlighting the imperative for customized treatment modalities.

Optimized guideline-directed medical therapy (GDMT) has been the cornerstone of treatment for heart failure and associated valvular diseases, including AFMR13. GDMT for heart failure with reduced LVEF typically includes a combination of a beta-blockers, ACE inhibitor, angiotensin receptor blockers or ARNI, a mineralocorticoid receptor antagonist, an SGLT2 inhibitor, and diuretics, along with anticoagulation for atrial fibrillation and cardiac resynchronization therapy for specific patients. However, the effectiveness of GDMT in treating AFMR specifically in whom the LVEF is typically preserved (≥50%) is not well-established14, as most prior studies have focused on PMR or heart failure with reduced ejection fraction. From the pathophysiological perspective of AFMR, strategies that restore sinus rhythm from atrial fibrillation have the potential to improve the prognosis of AFMR. Atrial fibrillation cardioversion may reduce the severity of MR, restore atrial size, enhance cardiac diastolic function, and decrease the incidence of endpoint events15-19. Transcatheter edge-to-edge repair (TEER) has emerged as a promising intervention for MR, in all patients with ventricular FMR and in those with PMR who are at high or prohibitive surgical risk14,20-22. Recent studies have demonstrated the efficacy of TEER in reducing the severity of MR, improving symptoms, and enhancing quality of life in patients with secondary MR23-25. However, its role in AFMR, a subset of secondary MR, is less clear.

Given the distinct pathophysiology of AFMR and the lack of consensus on optimal management, there is a pressing need for clinical trials comparing the efficacy of TEER versus GDMT in this patient population. Such trials are crucial for informing clinical practice and guiding treatment decisions in AFMR. This clinical trial aims to compare the efficacy and safety of TEER and GDMT in the management of AFMR, filling a significant knowledge gap in current research and potentially influencing future guidelines and patient care strategies.

03

Conditions studied

  • Atrial Functional Mitral Regurgitation

Keywords

  • mitral regurgitation
  • heart failure with preserved ejection fraction
  • transcatheter edge-to-edge repair
  • atrial fibrillation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 years or older

  2. Echocardiographic core laboratory criteria (all must be present):

    1. Atrial FMR (FMR must be atrial in etiology without ventricular leaflet tethering)
    2. Severe MR (3+ or 4+) defined as either 1) an effective regurgitant orifice area (EROA) ≥0.3 cm² or pulmonary-venous systolic flow reversal (PSVFR), or 2) in the absence of PSVFR, EROA measures 0.20-0.29 cm² with one or more of the following: regurgitant volume ≥45 mL/beat, regurgitant fraction ≥40%, or vena contracta width ≥0.5 cm.
    3. LV ≥40% without more than mild regional wall motion abnormalities
    4. No or mild LV dilatation (LV end-diastolic volume index \<79 mL/m2 [male] or \<71 mL/m² [female])
    5. Left atrial dilation (left atrial volume index ≥34 mL/m²)
    6. Mitral annulus dilatation (AP diameter >35mm or AP diameter index ≥19mm/m²)

  3. The mechanism of the atrial FMR is likely either atrial fibrillation (persistent/permanent or paroxysmal [documented]) and/or HFpEF. If HFpEF, one or both of the following must also be present:

    1. TTE criteria of diastolic dysfunction i. Average E/e' ≥15, or ii. Average E/e' 9-14 plus both of the following:

1. Septal e' \<7 cm/s or lateral e' \<10 cm/s 2. TR Vmax >2.8 m/s (or PASP >35 mmHg if TR jet is adequate) AND/OR b) Invasive hemodynamic evidence (measured prior to randomization) of elevated LV filling pressures (PCWP (or LVEDP) ≥15 mmHg at rest or ≥25 mmHg with exercise; Note: If PCWP is 12 to 15 mmHg, the patient may be given a 7-10 mL/kg (approximately 500 mL) rapid infusion (over 5-10 min) of normal saline; if PCWP rises to ≥18 mmHg, the subject may be randomized.

4. NT-proBNP ≥300 pg/mL (or BNP ≥100 pg/mL) if at the time of the test the patient is in sinus rhythm or NT-proBNP ≥600 pg/mL (or BNP ≥200 pg/mL) if the patient is in atrial fibrillation 5. Subject remains symptomatic ( class II, III or ambulatory IV) despite maximally tolerated doses of societal indicated class I GDMT for ≥2 months

a) Diuretics as needed to treat pulmonary congestion and peripheral edema b) If atrial fibrillation: Rate control medication to ensure heart rate \<110 bpm c) If HFpEF: i. SGLT2i for at least 2 months (required) ii. MRAs, e.g., spironolactone or finerenone) and angiotensin receptor-neprilysin inhibitors (ARNIs, e.g., sacubitril/valsartan) may be used at the discretion of each center (but should not be changed after randomization) 6. SBP \<140 mmHg and HR \<100 bpm (\<110 bpm if in atrial fibrillation) 7. Atrial fibrillation ablation is determined by the local heart team. If ablation is deemed necessary, it will be performed prior to enrollment; if ablation is considered unsuitable, no ablation will be performed after enrollment.

8. Anatomy suitable for TEER 9. The subject or legal guardian voluntarily agrees to comply with all provisions of this clinical trial, including the possibility of being randomly assigned to the control group, as well as participating in all necessary postoperative follow-ups and provides written .

Exclusion criteria

Exclusion Criteria:

  1. Patient is clinically unstable or has been hospitalized within the prior 30 days.
  2. Primary degenerative or organic mitral valve disease such as prolapse, Barlow's disease, rheumatic heart valve disease causing leaflet thickening, leaflet clefts or perforation, endocarditis, etc. Note: A small amount of mitral leaflet thickening or other abnormality may be present, but it cannot be the primary cause of MR.
  3. Moderate or severe mitral annular calcification, or any degree of mitral annular calcification if it is the primary cause of the MR or would interfere with TEER.
  4. Mitral valve area (MVA) \<4.0 cm² or mean trans-mitral valve gradient >4 mmHg.
  5. Intent to treat the patient with mitral valve surgery within the next 24 months if randomized to control
  6. Known cardiomyopathy such as amyloid, sarcoid or hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or pericardial diseases such as constrictive pericarditis.
  7. Previous mitral valve surgery or transcatheter mitral valve intervention.
  8. Concomitant severe (4+ or 5+) tricuspid regurgitation.
  9. Concomitant severe disease of the pulmonary valve.
  10. Concomitant severe disease of the aortic valve.
  11. Moderate or severe right ventricular dysfunction, defined as TAPSE≤14mm or RVFAV≤30% on the baseline echo.
  12. Severe pulmonary hypertension defined as RVSP≥70mmHg on the baseline echo.
  13. AF ablation procedure within 2 months prior to enrollment.
  14. Any implantation of an intracardiac pressure monitoring system, baroreceptor activation therapy, cardiac contractility modulation within 2 months prior to enrollment or planned any time after enrollment.
  15. If taking a chronic oral anticoagulation: Inability to discontinue it or bridge it with heparin for several days prior to the procedure
  16. If not taking a chronic oral anticoagulation: Inability to tolerate aspirin or clopidogrel for 6 months
  17. Untreated coronary artery disease requiring revascularization
  18. Coronary artery bypass grafting (CABG) within prior 30 days
  19. Percutaneous coronary intervention (PCI) within prior 30 days
  20. Acute cerebrovascular event within prior 30 days or any prior intracranial hemorrhage
  21. Allergic to heparin or any study drug that cannot be pre-medicated
  22. Any to transesophageal echocardiography
  23. IVC filter in place
  24. Any atrial septal pathology interfering with mitral TEER (e.g. atrial septal aneurysm, device in place across the atrial septum, etc.)
  25. Any major surgery within prior 30 days or anticipated within 24 months
  26. Non-cardiac disease with a \<24 months
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Device group (Interventional group)

    Patients will receive transcatheter edge-to-edge repair for atrial functional mitral regurgitation plus maximally tolerated guideline-directed medical therapy for cardiovascular disease

    Device: Transcatheter Edge-to-Edge Repair · Drug: Guideline-Directed Medical Therapy (GDMT) for cardiovascular disease

  • Active comparator
    no Device group (Control Group)

    Patients will receive maximally tolerated guideline-directed medical therapy for cardiovascular disease

    Drug: Guideline-Directed Medical Therapy (GDMT) for cardiovascular disease

Interventions

  • DeviceTranscatheter Edge-to-Edge Repair

    The intervention to be implemented in this clinical study is Transcatheter Edge-to-Edge Repair (TEER), a minimally invasive, image-guided interventional procedure specifically designed for the treatment of mitral regurgitation (MR)

  • DrugGuideline-Directed Medical Therapy (GDMT) for cardiovascular disease

    Guideline-Directed Medical Therapy (GDMT) for cardiovascular disease

06

What researchers measure

Primary outcomes

  1. Time to first occurrence of a composite event of death from any cause, hospitalization for [worsening] heart failure or unplanned outpatient [worsening] heart failure event within 24 months

    Time to first occurrence of a composite event of death from any cause, hospitalization for \[worsening\] heart failure or unplanned outpatient \[worsening\] heart failure event within 24 months * Hospitalization for heart failure requires an admission to an in-patient unit or an emergency room stay for ≥24 hours (or \<24 hours if subject dies in the emergency room). * Outpatient worsening heart failure requires an unplanned visit to a doctor's office, urgent care center or emergency room visit with stay \<24 hours. * Worsening heart failure must be present for both conditions, the definition of which requires all three of the following to be present: 1. Deterioration of HF symptoms: at least 1 of the following symptoms 2. Deterioration of HF signs: 2 physical examination findings or 1 physical examination + 1 laboratory or invasive finding 3. Urgent escalation of therapy

    Time frame: From enrollment to the end of treatment at 24 months

  2. Number of participants with the primary safety endpoint (device group only)

    Primary safety endpoint is the composite of the following events within 30 days * Stroke * Myocardial Infraction * Single-Leaflet Device Attachment (SLDA) * ECL-confirmed mitral stenosis requiring surgery * Any device-related complication requiring nonelective cardiovascular surgery * Durable left ventricular assist device (LVAD) implant * Heart transplantation

    Time frame: From enrollment to the end of treatment at 30 days

Secondary outcomes

  1. Number of participants with hospitalization for [worsening] heart failure or outpatient [worsening] heart failure events

    All hospitalization for \[worsening\] heart failure or outpatient \[worsening\] heart failure events at 24 months

    Time frame: From enrollment to the end of treatment at 24 months

  2. Number of participants with all-cause death

    All-cause mortality at 24 months

    Time frame: From enrollment to the end of treatment at 24 months

  3. Degree of MR reduction

    MR reduction from baseline to 30 days, 12 months and 24 months

    Time frame: From enrollment to the end of treatment at 24 months

  4. Rate of MR severity of 1+ or less

    MR severity of 1+ or less at 30 days, 12 months and 24 months

    Time frame: From enrollment to the end of treatment at 24 months

  5. Rate of MR severity of 2+ or less

    Rate of MR severity of 2+ or less at 30 days, 12 months and 24 months

    Time frame: From enrollment to the end of treatment at 24 months

  6. Degree of NYHA functional class change

    Degree of NYHA functional class change from baseline to 6 months, 12 months and 24 months

    Time frame: From enrollment to the end of treatment at 24 months

  7. Improvement in Kansas City Cardiomyopathy Questionnaire score (0-100, higher scores indicate a better outcome）

    Improvement in KCCQ score from baseline to 6 months, 12 months and 24 months

    Time frame: From enrollment to the end of treatment at 24 month

  8. Improvement in 6-minute walk distance

    Improvement in 6-minute walk distance from baseline to 6 months, 12 months and 24 months

    Time frame: From enrollment to the end of treatment at 24 months

  9. Reduction in left atrial volume index

    Reduction in LAVI from baseline to 12 months and 24 months

    Time frame: From enrollment to the end of treatment at 24 months

  10. Number of participants with a secondary safety endpoint (device group only)

    Secondary safety endpoint is a composite of stroke, myocardial infraction, non-elective cardiovascular surgery for device related complications, durable LVAD implant or heart transplantation

    Time frame: From enrollment to the end of treatment at 24 months

Other outcomes

  1. MR Severity Grade

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years:

    Time frame: From enrollment to the end of treatment at 5 years

  2. Regurgitant Volume

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  3. Regurgitant Fraction

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  4. Left Ventricle End Diastolic Volume (LVEDV)

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  5. Left Ventricular End Systolic Volume (LVESV)

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  6. Left Ventricular End Diastolic Dimension (LVEDD)

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  7. Left Ventricular End Systolic Dimension (LVESD)

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  8. Left Ventricular Ejection Fraction (LVEF)

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  9. Right Ventricular Systolic Pressure (RVSP)

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  10. Mitral Valve Area

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  11. Mitral Valve Gradient

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  12. Left atrial strain

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  13. Left ventricular strain

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  14. Right ventricular strain

    The echocardiographic endpoints will be reported at baseline, 30 days, 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  15. All-cause death

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  16. Cardiovascular death

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  17. Non-cardiovascular death

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  18. Hospitalization for [worsening] heart failure or outpatient worsening heart failure events

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  19. Hospitalizations for [worsening] heart failure

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  20. Outpatient [worsening] heart failure events

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  21. Durable LVAD or heart transplantation

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  22. NYHA Functional Class

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  23. 6-minute walk distance (6MWD)

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  24. Kansas City Cardiomyopathy Questionnaire score (0-100, higher scores indicate a better outcome）

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  25. Mitral valve surgery (including type of surgery)

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  26. New use of CRT

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  27. Durable LVAD implant

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  28. Heart transplantation

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  29. Repeat TEER (including reason for re-intervention)

    The clinical endpoints will be reported at 30 days and 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  30. Responder analysis for 6 Minutes Walk Distance, where responder is defined as alive and experiencing an improvement of 25 meters and 50 meters (difference in proportion of responders between Device and Control groups).

    The clinical endpoints will be reported at 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  31. Responder analysis for left atrial volume Index, where responder is defined as alive and experiencing an improvement of ≥5 mL/m2 (difference in proportion of responders between Device and Control groups)

    The clinical endpoint will be reported at 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  32. Responder analysis for Left Ventricular End Diastolic Volume Index, where responder is defined as alive and experiencing an improvement of ≥12 mL/m2 (difference in proportion of responders between Device and Control groups)

    The clinical endpoints will be reported at 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  33. Responder analysis for Kansas City Cardiomyopathy Questionnaire score, where responder is defined as alive and experiencing an improvement of ≥5 points (difference in proportion of responders between Device and Control groups)

    The clinical endpoints will be reported at 6month, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

  34. Each subscale for Kansas City Cardiomyopathy Questionnaire score (difference in means between Device and Control groups)

    The clinical endpoints will be reported at 6 months, 12 months, 24 months, 3 years and 5 years

    Time frame: From enrollment to the end of treatment at 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Feb 2030, 44 months after the start.

Of 143 interventional studies with no phase under Mitral Valve Insufficiency, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 108. This study's planned 44 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2026
First posted
Feb 17, 2026
StartActual
Jun 1, 2026
Primary completionEst.
Feb 25, 2030
CompletionEst.
Feb 25, 2030
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07414225
Lead sponsor
Beijing Anzhen Hospital
Responsible party
Guangyuan Song (Director of interventional center of valvular heart disease, Beijing Anzhen Hospital) — Principal investigator
First posted
Feb 17, 2026
Start date
Jun 1, 2026
Primary completion
Feb 25, 2030 (estimated)
Completion
Feb 25, 2030 (estimated)
Last update
Sep 11, 2026

Study contacts

Sanshuai Chang, M.D.
Contact
18501369869@163.com
+8618501369869
Guangyuan Song, M.D.
Contact
songgy_anzhen@vip.163.com
+8613801120805
Guangyuan Song, M.D.
principal investigator · Beijing Anzhen Hospital
Gregg W. Stone, M.D.
principal investigator · Academic Affairs for the Mount Sinai Heart Health System

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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