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

NCT07414225 | Not Yet Recruiting DMC

• 2 other identifiers: BeijingAnzhen202601102026
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Functional Mitral Regurgitation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  From enrollment to the end of treatment at 24 months

• 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

  From enrollment to the end of treatment at 30 days

Secondary Outcomes (10)

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

  From enrollment to the end of treatment at 24 months

• Number of participants with all-cause death

  From enrollment to the end of treatment at 24 months

• Degree of MR reduction

  From enrollment to the end of treatment at 24 months

• Rate of MR severity of 1+ or less

  From enrollment to the end of treatment at 24 months

• Rate of MR severity of 2+ or less

  From enrollment to the end of treatment at 24 months

Other Outcomes (34)

• MR Severity Grade

  From enrollment to the end of treatment at 5 years

• Regurgitant Volume

  From enrollment to the end of treatment at 5 years

• Regurgitant Fraction

  From enrollment to the end of treatment at 5 years

Study Arms (2)

Device group (Interventional group)

EXPERIMENTAL

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

no Device group (Control Group)

NO INTERVENTION

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

Interventions

Transcatheter Edge-to-Edge Repair DEVICE

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)

Device group (Interventional group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Echocardiographic core laboratory criteria (all must be present):
• Atrial FMR (FMR must be atrial in etiology without ventricular leaflet tethering)
• 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.
• LV ejection fraction ≥50% without more than mild regional wall motion abnormalities
• No or mild LV dilatation (LV end-diastolic volume index \<79 mL/m2 \[male\] or \<71 mL/m² \[female\])
• Left atrial dilation (left atrial volume index ≥34 mL/m²)
• Mitral annulus dilatation (AP diameter \>35mm)
• 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:
• TTE criteria of diastolic dysfunction i. Average E/e' ≥15, or ii. Average E/e' 9-14 plus both of the following:
• \. 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.
• \. 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 (NYHA 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.
• \. 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 informed consent.

You may not qualify if:

• Patient is clinically unstable or has been hospitalized within the prior 30 days.
• 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.
• 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.
• Mitral valve area (MVA) \<4.0 cm² or mean trans-mitral valve gradient \>4 mmHg.
• Intent to treat the patient with mitral valve surgery within the next 24 months if randomized to control
• Known cardiomyopathy such as amyloid, sarcoid or hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or pericardial diseases such as constrictive pericarditis.
• Previous mitral valve surgery or transcatheter mitral valve intervention.
• Any severe valvular disease of the pulmonary valve or tricuspid valve, or moderate or severe disease of the aortic valve.
• Moderate or severe right ventricular dysfunction, defined as TAPSE≤14mm or RVFAV≤30% on the baseline echo.
• Severe pulmonary hypertension defined as RVSP≥70mmHg on the baseline echo.
• AF ablation procedure within 2 months prior to enrollment.
• 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.
• If taking a chronic oral anticoagulation: Inability to discontinue it for several days prior to the procedure
• If not taking a chronic oral anticoagulation: Inability to tolerate aspirin or clopidogrel for 6 months
• Untreated clinically significant coronary artery disease requiring revascularization

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guangyuan Song, M.D.

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

• Gregg W. Stone, M.D.

  Academic Affairs for the Mount Sinai Heart Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanshuai Chang, M.D.

CONTACT

+8618501369869; 18501369869@163.com

Guangyuan Song, M.D.

CONTACT

+8613801120805; songgy_anzhen@vip.163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of interventional center of valvular heart disease

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 17, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): February 25, 2030
• Study Completion (Estimated): February 25, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)