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RecruitingNCT06162780Updated Mar 15, 2024

TEER for Severe DMR of Low to Intermediate Surgery Risk

An observational study in Mitral Regurgitation, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
160
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

This is a proposed multicentre, prospective cohort study to enrol and follow up severe DMR patients of low to intermediate surgery risk who underwent TEER, and surgical historical controls. The primary efficacy endpoints are all-cause death and cumulative composite event rate of worsening heart failure at 24 months postoperatively, and the primary safety endpoints are death, secondary surgery, and various complications at 30 days postoperatively. The study aims to investigate the efficacy and safety of TEER in surgical low-intermediate-risk patients with severe DMR, and to inform the subsequent clinical application.

02

Conditions studied

  • Mitral Regurgitation

Keywords

  • degenerative mitral regurgitation
  • transcatheter mitral valve edge-to-edge repair
  • surgery risk
03

In context

Mitral Valve Insufficiency

459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.

This study's planned enrollment of 160 is close to the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.

Browse Mitral Valve Insufficiency studies →

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

severe DMR patients of low to intermediate surgery risk who underwent TEER.

Eligibility 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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
160 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • TEER group

    Severe DMR patients of low to intermediate surgery risk who underwent TEER.

    Diagnostic Test: ultrasonic cardiography (UCG) · Procedure: TEER

Interventions

  • Diagnostic testultrasonic 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.

  • ProcedureTEER

    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.

06

What researchers measure

Primary outcomes

  1. cumulative composite event rate of the main adverse events

    The main adverse events: death, acute myocardial infarction, requiring secondary therapy for valve treatment failure, requiring non-scheduled cardiovascular emergency surgery for main complications, stroke, kidney failure, deep infection, \>48 hours mechanical ventilation, new-onset atrial fibrillation, deep vein thrombosis, pulmonary embolism, sepsis, haemorrhage, blood transfusion \>2U

    Time frame: time of operation to 30 days after operation

  2. cumulative composite event rate of all-cause death and worsening heart failure

    all-cause mortality: deaths from all causes including cardiovascular and non-cardiovascular deaths. worsening heart failure: heart failure rehospitalization, worsening heart failure needing emergency room visit, NYHA classification increased by one, ineffective escalation of medication on outpatient service, receiving intravenous diuretic therapy on outpatient or emergency service.

    Time frame: time of operation to 24 months after operation

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06162780
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
Peking University Shenzhen Hospital, Dongguan People's Hospital, First People's Hospital of Foshan, The Second People's Hospital of Foshan, The First Affiliate Hospital of Guangxi Medical College, Affiliated Hospital of Guangdong Medical University, Huizhou The Third People's Hospital, Jiangmen Central Hospital, Guangzhou Panyu Center Hospital, Meizhou People's Hospital, Suzhou Municipal Hospital, The General Hospital of Southern Theater Command, People's Hospital of Nanhai District, Foshan, Nanfang Hosptial, China, Southern Medical University, China, First Affiliated Hospital of Shantou University Medical College, Shantou Central Hospital, Sichuan Provincial People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, People's Hospital of Xinjiang Uygur Autonomous Region, Yueyang Central Hospital, ZhuZhou Central Hospital, First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Fifth Affiliated Hospital, Sun Yat-Sen University, Central South University Xiangya Hospital, Zhongshan People's Hospital, Guangdong, China, Foshan Fosun Chancheng Hospital
Responsible party
Yangxin Chen (Chief physician, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University) — Principal investigator
First posted
Dec 8, 2023
Start date
Jan 1, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Mar 15, 2024

Study contacts

Yangxin Chen, PhD
Contact
chenyx39@mail.sysu.edu.cn
8681332360
Maohuan Lin
Contact
chenyx39@mail.sysu.edu.cn
8681332360
Yangxin Chen, PhD
principal investigator · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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