Mitral RegurgitationNCT05021614
Valveclip® Transcatheter Mitral Valve Repair Study
A study testing Valveclip® Transcatheter mitral valve repair in people with Mitral Regurgitation, run by Shanghai NewMed Medical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Valveclip® Transcatheter mitral valve repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2021to Sep 2027
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe mitral regurgitation≥3+ (moderate or above degenerative mitral regurgitation disease, or with stenosis is included);
- Age≥70 years; or patients who are 60~70 years old, and the STS risk score indicate that participants are at high risk of traditional surgery or cannot tolerate traditional thoracotomy;
- 4) Left ventricular ejection fraction≥30%； 5) As assessed by multidisciplinary cardiac team (at least two cardiac surgeons/one cardiologist), patients who are at extremely high-risk or unsuitable for routine mitral valve surgery with evaluation; 6) Patients who understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
- Anatomy selection Criteria：
- The regurgitant jet of mitral valve originates from the A2 and P2 (the lesions of A2/P2 in mitral valve causes regurgitation);
- The width of the mitral valve prolapsed area is ≤15mm, Height of Prolapse ≤10mm or coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets>1cm (conforming to EVEREST II recommended mitral valve interventional edge-to-edge repair standards);
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- Effective mitral valve orifice area≥ 4.0cm2;
- No obvious calcification of the mitral valve annulus and valve leaflets;
- Patient's anatomical conditions allow transseptal approach.
Who cannot join
- Previous cardiac mitral valve surgery;
- Patients with Infective endocarditis or having an active infection;
- Patients with mitral regurgitation caused by pure mitral stenosis;
- Combined with untreated severe coronary artery disease
- Pulmonary hypertension (pulmonary artery systolic pressure>70mmHg);
- Patients with severe right heart failure;
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- Patients are extremely weak and cannot tolerate general anesthesia or are in shock that circulatory support is needed;
- Patients with hypertrophic cardiomyopathy, restrictive cardiomyopathy, and constrictive pericarditis;
- Patients receiving chronic dialysis;
- Patients with clear coagulation dysfunction and severe coagulopathy;
- Patients with clear contraindications to anticoagulant drugs;
- Patients with stroke or transient ischemic attack within 30 days;
- Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;
- Patients who require surgery or interventional therapy for other valvular lesions;
- Patients with severe macrovascular lesions requiring surgical treatment;
- Patients' imaging examinations suggest that the anatomy of the heart and valves are inappropriate;
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
Department of Cardiology, West China Hospital, Sichuan University
Sichuan
mao Chen, Chief
About this study
Official title: Evaluation of the Efficacy and Safety of the Transcatheter Mitral Valve Repair System in Patients With Moderate and Above Degenerative Mitral Regurgitation at High Surgical Risk
The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.
Read the detailed description
This study is a prospective,multi-center, single-arm, safety and performance clinical study.
- Conditions
- Mitral Regurgitation
- Being tested
- Valveclip® Transcatheter mitral valve repair
- 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.
Valveclip® Transcatheter mitral valve repairDevice
Transcatheter mitral valve repair system
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Transcatheter Mitral Valve Repair with Valveclip® Receives: Device: Valveclip® Transcatheter mitral valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of product
Efficacy of product is defined as the proportion of participants meeting effective standards after surgery (freedom from death, mitral valve reoperation or MR>2+ at 12 months).
Measured: 12 months
Secondary outcomes (4)
Efficacy of product
Efficacy of product is defined as the proportion of participants meeting effective standards after surgery (freedom from death, mitral valve reoperation or MR>2+ at 30 days, 180 days, 2 to 5 years).
Measured: 30 days, 180 days, 2 to 5 years
Rate of Cardiovascular related mortality
Cardiovascular related mortality after Transcatheter Mitral Valve Repairment
Measured: 30 days, 180 days, 1 year, 2 to 5 years
Rate of Severe adverse events
Severe adverse events after Transcatheter Mitral Valve Repairment (including death, stroke, myocardial infarction, reoperation, instrumental non-selective cardiovascular surgery, renal failure, and adverse events related to transfemoral vein septal approach surgery, etc.）
Measured: 30 days, 180 days, 1 year, 2 to 5 years
Quality of life Improvement
The 12-Item Short-Form Health Survey(SF-12)
Measured: 30 days, 180 days, 1 year, 2 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start24 Sep 2021
- Primary completionJun 2024 (estimated)
- Study completionSep 2027 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai NewMed Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- mao Chen, Chief, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021614
- Sponsor's protocol ID
- M-clip-2020-09
- Status last verified
- Nov 2023
- First submitted
- 16 Aug 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the Transcatheter Mitral Valve Repair System in Patients With Moderate and Above Degenerative Mitral Regurgitation at High Surgical Risk
- ClinicalTrials.gov ID
- NCT05021614
- Acronym / sponsor ID
- M-clip-2020-09
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai NewMed Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 25 Aug 2021 (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.
The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.
Detailed description
This study is a prospective,multi-center, single-arm, safety and performance clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Valveclip® Transcatheter mitral valve repairTranscatheter Mitral Valve Repair with Valveclip® |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Severe mitral regurgitation≥3+ (moderate or above degenerative mitral regurgitation disease, or with stenosis is included);
- Age≥70 years; or patients who are 60~70 years old, and the STS risk score indicate that participants are at high risk of traditional surgery or cannot tolerate traditional thoracotomy;
- 4) Left ventricular ejection fraction≥30%； 5) As assessed by multidisciplinary cardiac team (at least two cardiac surgeons/one cardiologist), patients who are at extremely high-risk or unsuitable for routine mitral valve surgery with evaluation; 6) Patients who understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
- Anatomy selection Criteria：
- The regurgitant jet of mitral valve originates from the A2 and P2 (the lesions of A2/P2 in mitral valve causes regurgitation);
Key exclusion criteria (16 listed)
- Previous cardiac mitral valve surgery;
- Patients with Infective endocarditis or having an active infection;
- Patients with mitral regurgitation caused by pure mitral stenosis;
- Combined with untreated severe coronary artery disease
- Pulmonary hypertension (pulmonary artery systolic pressure>70mmHg);
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 |
|---|---|---|
| Valveclip® Transcatheter mitral valve repairTranscatheter mitral valve repair system | Device | Treatment |
Primary outcome
Efficacy of product
Time frame: 12 months
Efficacy of product is defined as the proportion of participants meeting effective standards after surgery (freedom from death, mitral valve reoperation or MR>2+ at 12 months).
4 secondary outcomes
Efficacy of product
Time frame: 30 days, 180 days, 2 to 5 years
Rate of Cardiovascular related mortality
Time frame: 30 days, 180 days, 1 year, 2 to 5 years
Rate of Severe adverse events
Time frame: 30 days, 180 days, 1 year, 2 to 5 years
Quality of life Improvement
Time frame: 30 days, 180 days, 1 year, 2 to 5 years
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 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
mao Chen, Chief principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valveclip® Transcatheter mitral valve repair in people with Mitral Regurgitation, run by Shanghai NewMed Medical Co., Ltd. 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?
The sponsor lists 9 inclusion and 16 exclusion criteria. 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 18 Nov 2023. 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 chunyang Wang, CRA ((86)-21-20788668, cywang@newmed.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of product (time frame: 12 months). 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 18 Nov 2023.