TEER for Severe DMR of Low to Intermediate Surgery Risk
NCT ID: NCT06162780
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
160 participants
OBSERVATIONAL
2024-01-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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TEER group
Severe DMR patients of low to intermediate surgery risk who underwent TEER.
ultrasonic cardiography (UCG)
Trans-thoracic echocardiography (TTE) is performed in the resting position. Trans-esophageal echocardiography (TEE) is performed under surface anaesthesia with bupivacaine or intravenous anaesthesia. We comprehensively assess the severity of mitral regurgitation according to American Society of Echocardiography (ASE) guideline.
TEER
Two commercial cliping systems are available for clinical use: the G3 MitraclipTM and the G4 MitraclipTM (Abbott), DragonflyTM (Dejin), which will be introduced to the Chinese market in 2024, with the specific choice determined by the operator. The patient receives general anaesthesia (intravenous and endotracheal). The operator performs the procedure according to the recommended surgical steps in the product manual, guided by X-ray and trans-esophageal echocardiography. Postoperative MR ≤2+ is considered successful, and if the result is unsatisfactory, 1-2 additional clips are given.
Interventions
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ultrasonic cardiography (UCG)
Trans-thoracic echocardiography (TTE) is performed in the resting position. Trans-esophageal echocardiography (TEE) is performed under surface anaesthesia with bupivacaine or intravenous anaesthesia. We comprehensively assess the severity of mitral regurgitation according to American Society of Echocardiography (ASE) guideline.
TEER
Two commercial cliping systems are available for clinical use: the G3 MitraclipTM and the G4 MitraclipTM (Abbott), DragonflyTM (Dejin), which will be introduced to the Chinese market in 2024, with the specific choice determined by the operator. The patient receives general anaesthesia (intravenous and endotracheal). The operator performs the procedure according to the recommended surgical steps in the product manual, guided by X-ray and trans-esophageal echocardiography. Postoperative MR ≤2+ is considered successful, and if the result is unsatisfactory, 1-2 additional clips are given.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Peking University Shenzhen Hospital
OTHER
Dongguan People's Hospital
OTHER_GOV
First People's Hospital of Foshan
OTHER
The Second People's Hospital of Foshan
OTHER
The First Affiliate Hospital of Guangxi Medical College
UNKNOWN
Affiliated Hospital of Guangdong Medical University
OTHER
Huizhou Third People's Hospital
UNKNOWN
Jiangmen Central Hospital
OTHER
Guangzhou Panyu Center Hospital
UNKNOWN
Meizhou People's Hospital
OTHER
Suzhou Municipal Hospital
OTHER
The General Hospital of Southern Theater Command
OTHER
People's Hospital of Nanhai District, Foshan
UNKNOWN
Nanfang Hosptial, China
UNKNOWN
Southern Medical University, China
OTHER
First Affiliated Hospital of Shantou University Medical College
OTHER
Shantou Central Hospital
OTHER
Sichuan Provincial People's Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
People's Hospital of Xinjiang Uygur Autonomous Region
OTHER
Yueyang Central Hospital
OTHER
ZhuZhou Central Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Fifth Affiliated Hospital, Sun Yat-Sen University
OTHER
Central South University Xiangya Hospital
UNKNOWN
Zhongshan People's Hospital, Guangdong, China
OTHER
Foshan Fosun Chancheng Hospital
UNKNOWN
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Yangxin Chen
Chief physician
Principal Investigators
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Yangxin Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
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Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SYSKY-2023-1019-03
Identifier Type: -
Identifier Source: org_study_id
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