Actively Recruiting
TEER for Severe DMR of Low to Intermediate Surgery Risk
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-03-15
160
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
P
Peking University Shenzhen Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
To investigate the efficacy and safety of transcatheter mitral valve edge-to-edge repair (TEER) for severe degenerative mitral regurgitation (DMR) patients of low to intermediate surgery risk.
CONDITIONS
Official Title
TEER for Severe DMR of Low to Intermediate Surgery Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Severe degenerative mitral regurgitation graded 3+ or higher by ultrasound measures including effective regurgitant orifice area ≥ 0.3 cm², regurgitant volume ≥ 45 ml, or regurgitant fraction ≥ 40%
- Symptomatic heart failure (NYHA class II-IV), or asymptomatic with specific heart measurements or conditions such as left ventricular end systolic dimension ≥ 40 mm, ejection fraction ≤ 60%, new atrial fibrillation, or resting pulmonary artery systolic pressure > 50 mmHg
- Surgical indications evaluated by cardiac team with American Association of Thoracic Surgeons Score less than 8
- Signed informed consent and agreement to regular follow-up for at least one year
You will not qualify if you...
- Active infective endocarditis especially in the mitral valve area, or mitral valve perforation
- Rheumatic mitral valve disease, mitral stenosis, or mitral valve orifice area less than 4 mm²
- Combined valve lesions requiring surgery, such as severe tricuspid regurgitation or aortic valve disease
- Presence of tumor, thrombus, or redundant organisms in heart chambers
- Unable to tolerate intraoperative or postoperative antithrombotic therapy
- Acute degenerative mitral regurgitation caused by acute papillary muscle rupture
- Anatomical conditions leading to low success rate for TEER, including unsuitable venous approach, severe leaflet calcification, mitral valve cleft, multiple regurgitant flows, Barlow disease, leaflet length less than 7 mm, flail gap greater than 10 mm, or flail width greater than 15 mm
- Severe cardiac insufficiency (NYHA class IV or left ventricular ejection fraction less than 20%), end-stage heart failure relying on circulation aids or awaiting heart transplant
- Planned implantation of heart failure devices like CRT/CRT-D or CCM
- Untreated severe coronary artery stenosis or other cardiac macrovascular diseases requiring surgery
- Hypertrophic, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart diseases causing heart failure besides dilated heart disease
- Severe pulmonary hypertension (PASP > 70 mmHg) or pulmonary arterial hypertension not caused by left heart disease
- Recent acute myocardial infarction within 4 weeks
- Recent acute cerebrovascular accident within 30 days
- Recent acute peptic ulcer or upper gastrointestinal bleeding within 3 months
- Uncontrolled hyperthyroidism or autoimmune connective tissue diseases such as Behcet's disease or systemic lupus erythematosus
- Amyloidosis
- Severe infections or septicemia
- Severe liver failure or cirrhosis (Child-Pugh class C)
- Severe kidney failure (eGFR < 15 ml/min) or dialysis
- Hypotension or shock with low blood pressure and poor tissue perfusion
- Uncontrolled blood disorders including bleeding diseases, pulmonary embolism, deep vein thrombosis, or severe blood parameter abnormalities
- Contraindications for trans-esophageal echocardiography such as esophageal diseases or cervical spine instability
- Contraindications for intravenous anesthesia or allergies to anesthetics
- Pregnancy or breastfeeding
- No signed informed consent
- Expected survival less than one year
- Poor compliance expected to prevent follow-up
- Participation in other experimental drug or device studies that interfere with study endpoints
- Other reasons assessed by researchers making patient unsuitable for enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Y
Yangxin Chen, PhD
CONTACT
M
Maohuan Lin
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here