Actively Recruiting
Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).
Led by Xiamen Cardiovascular Hospital, Xiamen University · Updated on 2025-07-09
112
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. The experimental group will utilize the Structural Heart Surgery Assist System, while the control group will undergo manual TEER (e.g., MitraClip G4).
CONDITIONS
Official Title
Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Symptomatic moderate-to-severe or greater mitral regurgitation confirmed by transthoracic or transesophageal echocardiography
- Planned transcatheter edge-to-edge repair (TEER)
- For degenerative mitral regurgitation: high surgical risk by heart team assessment or patient declines surgery
- For functional mitral regurgitation: persistent heart failure symptoms (NYHA Class III/IVa) despite treatment for 1-3 months
- At least one hospitalization for heart failure in past 12 months or elevated BNP/NT-proBNP levels
- Left ventricular ejection fraction between 20% and 50% with left ventricular end-systolic diameter ≤70 mm
- Primary regurgitant jet is non-commissural and treatable by investigator
- Provides informed consent and agrees to follow-up
You will not qualify if you...
- Rheumatic mitral valve disease
- Uncorrected active infection
- Severe calcification or thickening making TEER unsuitable
- Intracardiac mass, thrombus, or vegetation
- Severe right heart dysfunction or severe pulmonary hypertension (systolic pulmonary artery pressure >70 mmHg)
- Severe left heart dysfunction (LVEF <20%)
- Acute myocardial infarction within 30 days prior to procedure
- Recent coronary artery bypass graft, percutaneous coronary intervention, or transcatheter aortic valve replacement within 30 days
- Planned tricuspid/aortic valve or major vascular intervention within 30 days after procedure
- Prior mitral valve repair or replacement
- Thrombosis in access vessels preventing catheter use
- Stroke or transient ischemic attack within 30 days or severe carotid stenosis
- Cardiomyopathies including hypertrophic, restrictive, infiltrative, constrictive pericarditis, or active endocarditis
- Hemodynamic instability or need for mechanical support
- Pacemaker, cardiac resynchronization therapy, or implantable defibrillator implanted within 30 days
- End-stage heart failure, post-heart transplant, or listed for transplant
- Hypersensitivity or contraindications to anticoagulants, antiplatelet agents, anesthesia, device materials, or contrast
- Pregnant or breastfeeding
- Participation in other clinical trials without meeting primary endpoints
- Other contraindications as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Structural Heart Disease Unit, Xiamen Cardiovacular Hospital
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
X
Xiang Chen, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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