Mitral Valve RegurgitationNCT04195984
Mi-thos® Transcatheter Mitral Valve Replacement Study
A study testing Mi-thos® valve and transapical delivery system in people with Mitral Valve Regurgitation, run by Shanghai NewMed Medical Co., Ltd. at 3 sites in China.
Trial summary
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mitral Valve Regurgitation
- What is being tested?
- Mi-thos® valve and transapical delivery system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 3 sitesChina
- Study dates
- 25 Mar 2021to Jan 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Severe mitral valve regurgitation ≥ 3+;
- High surgical risk fot open mitral valve surgery;
- Age ≥ 65 years old;
- Life expectancy > 12 months;
- As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery;
- Patients sign an informed consent form.
Who cannot join
- Previous cardiac mitral valve surgery;
- Active infections requiring antibiotic therapy;
- Clinically significant untreated Coronary Artery Disease (CAD);
- Pulmonary hypertension （Pulmonary systolic pressure > 70 mmHg）;
- Patients with severe right heart failure;
- Left ventricular ejection fraction <25%;
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- Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
- Dialysis patient;
- Patients with severe coagulopathy;
- Patients with contraindications to anticoagulant drugs;
- Patients with stroke or transient ischemic 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 disease requiring surgical treatment;
- Patients with more than 70% of carotid stenosis;
- To be allergic to contrast agents, nickel-titanium memory alloys or bovine-derived products;
- Patients with severe neurological disorders affecting cognitive ability;
- Patients with severe thoracic deformities.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Fuwai hospital
Beijing, Beijing Municipality, 100044
Zheng zhe, Chief, (+86)010-88396051, zhengzhe@fuwai.com
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Wang chunsheng, Chief, (86)021-64041990 ext. 2512, cswang@medmail.com.cn
- Recruiting
Xijing hospital
Xi’an, Shanxi, 710032
Yang jian, Chief, (+86)029-84774114, yangjian@fmmu.edu.cn
About this study
Official title: Evaluation of the Efficacy and Safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in Patients with Severe Mitral Valve Disease At High Surgical Risk.
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
Read the detailed description
The Mi-thos® study is an multicenter, single-arm, prospective, safety and performance clinical study.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Mi-thos® valve and transapical delivery system
- 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.
Mi-thos® valve and transapical delivery systemDevice
Transcatheter mitral valve replacement system
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Transcatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system Receives: Device: Mi-thos® valve and transapical delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from all-cause mortality
All-cause mortality after TMVR
Measured: 1 year
Secondary outcomes (4)
Freedom from all-cause mortality
All-cause mortality after TMVR
Measured: 30 days, 6months, 2-5 years
Severe adverse event rate
Severe adverse events rate after TMVR
Measured: 30 days, 6months, 1 year, 2-5 years
NYHA Heart Function Rating
NYHA Heart Function Rating after TMVR
Measured: 30 days, 6months, 1 year, 2-5 years
Kansas City Cardiomyopathy score
Kansas City Cardiomyopathy score after TMVR
Measured: 30 days, 6months, 1 year, 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start25 Mar 2021
- Primary completionMay 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve 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
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai NewMed Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wang chunsheng, Chief, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195984
- Sponsor's protocol ID
- M-valve-2018-06
- Status last verified
- Feb 2025
- First submitted
- 10 Dec 2019
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in Patients with Severe Mitral Valve Disease At High Surgical Risk.
- ClinicalTrials.gov ID
- NCT04195984
- Acronym / sponsor ID
- M-valve-2018-06
- Conditions
- Mitral Valve Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Shanghai NewMed Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 12 Dec 2019 (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 evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
Detailed description
The Mi-thos® study is an multicenter, single-arm, prospective, 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: Mi-thos® valve and transapical delivery systemTranscatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Severe mitral valve regurgitation ≥ 3+;
- High surgical risk fot open mitral valve surgery;
- Age ≥ 65 years old;
- Life expectancy > 12 months;
- As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery;
Key exclusion criteria (18 listed)
- Previous cardiac mitral valve surgery;
- Active infections requiring antibiotic therapy;
- Clinically significant untreated Coronary Artery Disease (CAD);
- Pulmonary hypertension （Pulmonary systolic pressure > 70 mmHg）;
- Patients with severe right heart failure;
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 |
|---|---|---|
| Mi-thos® valve and transapical delivery systemTranscatheter mitral valve replacement system | Device | Treatment |
Primary outcome
Freedom from all-cause mortality
Time frame: 1 year
All-cause mortality after TMVR
4 secondary outcomes
Freedom from all-cause mortality
Time frame: 30 days, 6months, 2-5 years
Severe adverse event rate
Time frame: 30 days, 6months, 1 year, 2-5 years
NYHA Heart Function Rating
Time frame: 30 days, 6months, 1 year, 2-5 years
Kansas City Cardiomyopathy score
Time frame: 30 days, 6months, 1 year, 2-5 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 13 Feb 2025.
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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.
Wang chunsheng, Chief principal investigator
Shanghai Zhongshan Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mi-thos® valve and transapical delivery system in people with Mitral Valve Regurgitation, run by Shanghai NewMed Medical Co., Ltd. at 3 sites 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 6 inclusion and 18 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 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Wang chunyang, 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?
Freedom from all-cause mortality (time frame: 1 year). 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 13 Feb 2025.