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New treatment option for Mitral R
Official title Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).
ClinicalTrials.gov ID: NCT07055919
What this study is testing
- What it's testing
- This trial aims to evaluate the safety and efficacy of the Structural Heart Surgery Assist System in assisting TEER for patients with moderate-to-severe or greater degenerative or functional mitral regurgitation (MR ≥3+). A prospective, multicenter, stratified randomized controlled design with non-inferiority comparison will be used.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years, regardless of gender.
- Symptomatic moderate-to-severe or greater mitral regurgitation (MR ≥3+) confirmed by transthoracic and/or transesophageal echocardiography (TTE/TEE)...
- Persistent heart failure symptoms (NYHA Class III/IVa) despite guidelines directed medical therapy (GDMT), revascularization, or cardiac...
- ≥1 hospitalization for heart failure within the past 12 months and/or BNP \>150 pg/mL or NT-proBNP \>600 pg/mL.
- Left ventricular ejection fraction (LVEF) ≥20% and ≤50%, with left ventricular end-systolic diameter (LVESD) ≤70 mm.
You likely can't join if
- Rheumatic mitral valve disease.
- Uncorrected active infection.
- Severe calcification or thickening in the clip coaptation zone, rendering TEER anatomically unsuitable.
- Intracardiac mass, thrombus, or vegetation on echocardiography.
- Severe right heart dysfunction (e.g., lower extremity edema with elevated jugular venous pressure and hepatomegaly) or severe pulmonary hypertension...
- Severe left heart dysfunction (LVEF \<20%).
See the full eligibility criteria
- Age ≥18 years, regardless of gender.
- Symptomatic moderate-to-severe or greater mitral regurgitation (MR ≥3+) confirmed by transthoracic and/or transesophageal echocardiography (TTE/TEE), with planned transcatheter edge-to-edge repair (TEER): For...
- Persistent heart failure symptoms (NYHA Class III/IVa) despite guidelines directed medical therapy (GDMT), revascularization, or cardiac resynchronization therapy (CRT) for 1-3 months.
- ≥1 hospitalization for heart failure within the past 12 months and/or BNP \>150 pg/mL or NT-proBNP \>600 pg/mL.
- Left ventricular ejection fraction (LVEF) ≥20% and ≤50%, with left ventricular end-systolic diameter (LVESD) ≤70 mm.
- Primary regurgitant jet is non-commissural and deemed treatable by the investigator (secondary jets, if present, must be clinically insignificant).
- Volunteerly provides informed consent, understands the trial objectives, and agrees to comply with follow-up.
- Rheumatic mitral valve disease.
- Uncorrected active infection.
- Severe calcification or thickening in the clip coaptation zone, rendering TEER anatomically unsuitable.
- Intracardiac mass, thrombus, or vegetation on echocardiography.
- Severe right heart dysfunction (e.g., lower extremity edema with elevated jugular venous pressure and hepatomegaly) or severe pulmonary hypertension (echocardiographic systolic pulmonary artery pressure \>70 mmHg).
- Severe left heart dysfunction (LVEF \<20%).
- Acute myocardial infarction (AMI) within 30 days prior to the procedure.
- Recent CABG, PCI, or TAVR within 30 days prior to the procedure.
- Planned tricuspid/aortic valve or major vascular intervention within 30 days post-procedure.
- Prior surgical or transcatheter mitral valve repair/replacement.
- Thrombosis in access vessels (e.g., femoral vein, inferior vena cava) impeding catheter advancement.
- Stroke/TIA within 30 days or severe carotid stenosis (\>70% by ultrasound).
- Cardiomyopathies or conditions including hypertrophic, restrictive, or infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis), constrictive pericarditis, or active endocarditis.
- Hemodynamic instability: Systolic blood pressure \<90 mmHg without afterload-reducing agents, cardiogenic shock, requirement for intra-aortic balloon pump (IABP) or hemodynamic support.
- Implanted pacemaker, CRT, or ICD within 30 days prior to the procedure.
- End-stage heart failure (ACC/AHA Stage D), post-heart transplant, or listed for transplant.
- Hypersensitivity or contraindications: ntolerance to anticoagulants, antiplatelet agents, or anesthesia, allergy to mitralclip materials (nickel/titanium, cobalt, chromium, polyester), severe contrast allergy precludes...
- Pregnant or breastfeeding.
- Participation in other clinical trials (drug/device) without meeting primary endpoints.
- Other contraindications per investigator judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.