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Mitral RegurgitationNCT06162780

TEER for Severe DMR of Low to Intermediate Surgery Risk

An observational study of Mitral Regurgitation, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral Regurgitation
What is being tested?
ultrasonic cardiography (UCG) and TEER
How many people
160 participants
Where
1 siteChina
Study dates
1 Jan 2024to Dec 2026
How long will I take part?
24 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Yangxin Chen, PhD, 8681332360, chenyx39@mail.sysu.edu.cn

    Yangxin Chen, PhD

    Recruiting

Other trials in China

About this study

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

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.

Being tested
ultrasonic cardiography (UCG), TEER
Keywords
degenerative mitral regurgitation, transcatheter mitral valve edge-to-edge repair, surgery risk
Medical subject headings
Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrasonic cardiography (UCG)Diagnostic test

    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.

  • TEERProcedure or surgery

    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.

Study groups in NCT06162780
Study groupRoleWhat they receive
TEER groupSevere DMR patients of low to intermediate surgery risk who underwent TEER.
Receives: Diagnostic Test: ultrasonic cardiography (UCG); Procedure: TEER

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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.

    Measured: time of operation to 24 months after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start1 Jan 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
160 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06162780
Sponsor's protocol ID
SYSKY-2023-1019-03
Status last verified
Mar 2024
First submitted
30 Nov 2023
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Regurgitation, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yangxin Chen, PhD (8681332360, chenyx39@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cumulative composite event rate of the main adverse events (time frame: time of operation to 30 days after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.

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