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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
- age ≥ 18 years old
- 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%.
- 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.
- The patient with American Association of Thoracic Surgeons Score (STS) <8 has surgical indications evaluated by cardiac team.
- 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.
- active infective endocarditis especially occurring in the mitral valve area, or mitral valve perforation.
- rheumatic mitral valve disease, mitral stenosis or mitral valve orifice area < 4mm^2.
- combined valve lesions requiring surgery, e.g. severe tricuspid regurgitation or aortic valve disease.
- the present of tumour, thrombus or redundant organisms in the heart chambers.
- inability to tolerate intraoperative or postoperative antithrombotic (anticoagulant or antiplate) therapy.
- acute DMR, e.g. DMR caused by acute papillary muscle rupture.
- 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.
- 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.
- proposed implantation of heart failure device such as cardiac resynchronization therapy/cardiac resynchronization therapy defibrillator (CRT/CRT-D) or cardiac contractility modulation (CCM).
- untreated severe coronary artery stenosis requiring coronary revascularization, or other cardiac macrovascular disease requiring surgery.
- hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or structural heart disease leading to heart failure other than dilated heart disease.
- severe pulmonary hypertension ( PASP >70 mmHg), or pulmonary hypertension associated with no-left heart disease, e.g. pulmonary arterial hypertension (PAH) etc.
- acute myocardial infarction within 4 weeks before operation.
- acute cerebrovascular accident within 30 days before operation.
- acute peptic ulcer or upper gastrointestinal bleeding within 3 months before operation.
- uncontrolled hyperthyroidism.
- uncontrolled autoimmune connective tissue diseases especially Behcet's disease and systemic lupus erythematosus (SLE).
- amyloidosis.
- severe infections, septicaemia.
- severe hepatic insufficiency, e.g. acute severe hepatitis, decompensated cirrhosis ( Child-Pugh class C)
- severe renal insufficiency ( chronic kidney disease (CKD) stage 5: estimated glomerular filtration rate (eGFR) < 15 ml/min or dialysis).
- hypotensive state, shock ( systolic blood pressure < 90mmHg or mean arterial pressure <70 mmHg with tissue hypoperfusion and urine output < 30 ml/h).
- 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.
- contraindication for TEE, e.g. oesophageal constriction, oesophageal tumour, oesophageal fistula, oesophageal varices, cervical vertebral instability, etc.
- contraindication for intravenous anaesthesia, e.g. allergy to anaesthetics.
- pregnancy or breastfeeding.
- The patient does not sign an informed consent form.
- expected survival less than 1 year.
- The patient with poor compliance is not thought to complete follow-up visits.
- 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.
- 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
- 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
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.
- Conditions
- Mitral Regurgitation
- 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 group | Role | What they receive |
|---|---|---|
| TEER group | Severe 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.
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
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.
- First posted8 Dec 2023
- Study start1 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Shenzhen Hospital, Dongguan People's Hospital, First People's Hospital of Foshan, The Second People's Hospital of Foshan, First Affiliated Hospital of Guangxi Medical University, Affiliated Hospital of Guangdong Medical University, The Third People's Hospital of Huizhou, Jiangmen Central Hospital, Guangzhou Panyu Center Hospital, Meizhou People's Hospital, Suzhou Municipal Hospital, The General Hospital of Southern Theater Command, Nanhai District People's Hospital, 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
- Principal investigator, Yangxin Chen, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Yangxin Chen, PhD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06162780
- Acronym / sponsor ID
- SYSKY-2023-1019-03
- Conditions
- Mitral Regurgitation
- Keywords
- degenerative mitral regurgitation, transcatheter mitral valve edge-to-edge repair, surgery risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Peking University Shenzhen Hospital, Dongguan People's Hospital, First People's Hospital of Foshan, The Second People's Hospital of Foshan, First Affiliated Hospital of Guangxi Medical University, Affiliated Hospital of Guangdong Medical University, The Third People's Hospital of Huizhou, Jiangmen Central Hospital, Guangzhou Panyu Center Hospital, Meizhou People's Hospital, Suzhou Municipal Hospital, The General Hospital of Southern Theater Command, Nanhai District People's Hospital, 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
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEER group | – | Diagnostic Test: ultrasonic cardiography (UCG), Procedure: TEERSevere DMR patients of low to intermediate surgery risk who underwent TEER. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- severe DMR patients of low to intermediate surgery risk who underwent TEER.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | TEER group |
| TEERTwo 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. | Procedure or surgery | TEER group |
Primary outcome
cumulative composite event rate of the main adverse events
Time frame: time of operation to 30 days after operation
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
cumulative composite event rate of all-cause death and worsening heart failure
Time frame: time of operation to 24 months after operation
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yangxin Chen, PhD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
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.