Transcatheter repair for severe mitral regurgitation in low to intermediate surgery risk patients
Official title: The Efficacy and Safety of TEER for Severe DMR Patients of Low to Intermediate Surgery Risk (TESLA-R)--a Multi-center, Prospective Cohort Study
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT06162780 · Data updated 2026-11-12
This study is testing if a new heart valve repair method can safely help people with severe mitral regurgitation who are at low to intermediate risk for surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | March 15, 2024 |
| Trial ID | NCT06162780 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with severe DMR and low to intermediate surgical risk, as determined by specific clinical criteria.
✕Probably not a fit
Patients with active infective endocarditis or those who do not meet the inclusion criteria will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the efficacy and safety of transcatheter mitral valve edge-to-edge repair (TEER) in patients with severe degenerative mitral regurgitation (DMR) who are considered to have low to intermediate surgical risk. It will involve a multicenter, prospective cohort design, enrolling patients who meet specific criteria and following them for 24 months postoperatively. The primary endpoints include all-cause mortality and the rate of worsening heart failure, while safety endpoints will assess complications and the need for secondary surgeries within 30 days. The study seeks to provide insights into the clinical application of TEER for this patient population.
Why it matters
Potential benefit: If successful, this study could offer a less invasive treatment option for patients with severe mitral regurgitation, potentially improving their quality of life and reducing surgical risks.
How similar studies have gone: Other studies have shown promising results with similar transcatheter approaches, indicating potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: the patient fully meets the following criteria. 1. age ≥ 18 years old 2. DMR ≥ grade 3+ according to UCG integrative approach, referring to the following quantitative indicators: 1) effective regurgitant orifice area (EROA) ≥0.3cm\^2; 2) regurgitant volume (RVol) ≥45ml; 3) regurgitant fraction (RF) ≥40%. 3. symptomatic heart failure ( New York Heart Association (NYHA) class II-IV ), or asymptomatic heart failure with left ventricular end systolic dimension (LVESd) ≥40mm or ejection fraction (EF) ≤60%, or new-onset atrial fibrillation, or resting pulmonary artery systolic pressure (PASP) \>50mmHg. 4. The patient with American Association of Thoracic Surgeons Score (STS) \<8 has surgical indications evaluated by cardiac team. 5. The patient has signed an informed consent form and agreed to regular follow-up for at least 1 year. Exclusion Criteria: the patient meets any of the following criteria. 1. active infective endocarditis especially occurring in the mitral valve area, or mitral valve perforation. 2. rheumatic mitral valve disease, mitral stenosis or mitral valve orifice area \< 4mm\^2. 3. combined valve lesions requiring surgery, e.g. severe tricuspid regurgitation or aortic valve disease. 4. the present of tumour, thrombus or redundant organisms in the heart chambers. 5. inability to tolerate intraoperative or postoperative antithrombotic (anticoagulant or antiplate) therapy. 6. acute DMR, e.g. DMR caused by acute papillary muscle rupture. 7. Due to the presence of certain anatomical conditions, patient has a low success rate for TEER assessed by the operator and is not appropriate for enrolment. The conditions include but are not limited to the followings: 1) the venous approach is not suitable for operation, such as thrombus in the approach and small vein diameter; 2) severe calcification presents in the flap leaflet clamping area; 3) mitral valve cleft; 4) multiple regurgitant flow, especially in the internal and external union junction area; 5) Barlow disease; 6) leaflet length \<7mm; 7) flail gap \>10mm; 8) flail width \>15mm. 8. severe cardiac insufficiency ( NYHA class IV or lefr ventricular ejection fraction (LVEF) \<20% ), end-stage heart failure status ( American College of Cardiology/American Heart Association (ACC/AHA) Stage D), relying on circulation aids or waiting for heart transplantation. 9. proposed implantation of heart failure device such as cardiac resynchronization therapy/cardiac resynchronization therapy defibrillator (CRT/CRT-D) or cardiac contractility modulation (CCM). 10. untreated severe coronary artery stenosis requiring coronary revascularization, or other cardiac macrovascular disease requiring surgery. 11. hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or structural heart disease leading to heart failure other than dilated heart disease. 12. severe pulmonary hypertension ( PASP \>70 mmHg), or pulmonary hypertension associated with no-left heart disease, e.g. pulmonary arterial hypertension (PAH) etc. 13. acute myocardial infarction within 4 weeks before operation. 14. acute cerebrovascular accident within 30 days before operation. 15. acute peptic ulcer or upper gastrointestinal bleeding within 3 months before operation. 16. uncontrolled hyperthyroidism. 17. uncontrolled autoimmune connective tissue diseases especially Behcet's disease and systemic lupus erythematosus (SLE). 18. amyloidosis. 19. severe infections, septicaemia. 20. severe hepatic insufficiency, e.g. acute severe hepatitis, decompensated cirrhosis ( Child-Pugh class C) 21. severe renal insufficiency ( chronic kidney disease (CKD) stage 5: estimated glomerular filtration rate (eGFR) \< 15 ml/min or dialysis). 22. hypotensive state, shock ( systolic blood pressure \< 90mmHg or mean arterial pressure \<70 mmHg with tissue hypoperfusion and urine output \< 30 ml/h). 23. uncontrolled diseases of the haematological system: acute gastrointestinal bleeding, intracranial haemorrhage or haemorrhage from other organs, acute pulmonary embolism or deep vein thrombosis, congenital or acquired haemorrhagic disease such as haemophilia, anaphylactic purpura and acute leukaemia, severe abnormalities in haematological parameters such as platelet count \<20\*10\^9/L and international normalized ratio (INR) \>3. 24. contraindication for TEE, e.g. oesophageal constriction, oesophageal tumour, oesophageal fistula, oesophageal varices, cervical vertebral instability, etc. 25. contraindication for intravenous anaesthesia, e.g. allergy to anaesthetics. 26. pregnancy or breastfeeding. 27. The patient does not sign an informed consent form. 28. expected survival less than 1 year. 29. The patient with poor compliance is not thought to complete follow-up visits. 30. The patient is participating in an experimental drug or other device study with an incomplete primary endpoint, or the patient is participating in an unfinished experimental drug or other device study that would clinically interfere with our study endpoints. 31. Due to other reasons the patient is not suitable for enrollment assessed by the researcher.
Where it's running
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Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Yangxin Chen, PhD — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Yangxin Chen, PhD
- Email: chenyx39@mail.sysu.edu.cn
- Phone: 8681332360
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Posterior Mitral Leaflet Replacement to Reduce Mitral Regurgitation
This early feasibility trial tests the MR-ace Implant and Delivery System to see if it can reduce symptoms and leaks in people with moderate-to-severe functional mitral regurgitation.
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Replacing the native mitral valve with the ReValve System
This study will test whether replacing the native mitral valve with the ReValve System helps adults with symptomatic, clinically significant mitral regurgitation who are appropriate candidates for mitral valve surgery.
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Mitral valve replacement with the SATURN TMVR system for severe mitral regurgitation
This study tests whether the SATURN TS transcatheter mitral valve replacement can be safely implanted and work well in adults with severe mitral regurgitation who are high-risk for open-heart surgery.
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Outcomes after new edge-to-edge mitral valve repair
This project will follow people with mitral regurgitation who receive transcatheter edge-to-edge repair at Amsterdam UMC to see how they do long-term and whether patient selection can be improved.
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Surgical implantation of a polymer prosthetic mitral or aortic valve
This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.
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GeminiOne transcatheter edge-to-edge repair for severe symptomatic mitral regurgitation
This trial will try the GeminiOne TEER system to treat adults with severe, symptomatic mitral regurgitation who are high surgical risk or have not improved with medical therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.