Mitral Valve RegurgitationNCT05784337
Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)
A study testing Mi-thos® Transcatheter Mitral Valve Replacement System in people with Mitral Valve Regurgitation, run by Shanghai NewMed Medical Co., Ltd. at 2 sites in China.
Trial summary
To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or who are not candidates for conventional surgery. 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® Transcatheter Mitral Valve Replacement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesChina
- Study dates
- 21 Apr 2021to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 regurgitation ≥ 3+;
- Patients with an STS score >8 or who have been evaluated by a cardiothoracic surgeon as high risk for conventional surgery or who cannot tolerate conventional open-heart surgery;
- Age ≥ 65 years old;
- Life expectancy > 12 months;
- 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%;
Show all 19Show fewer
- 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;
- Life expectancy < 12 months;
- Patients with severe thoracic deformities.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, 710032
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(First-in-Man Study)
To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or who are not candidates for conventional surgery.
Read the detailed description
The Mi-thos® study is a single-arm, prospective, safety and performance clinical study.
- Conditions
- Mitral Valve Regurgitation
- Being tested
- Mi-thos® Transcatheter Mitral Valve Replacement 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® Transcatheter Mitral Valve Replacement SystemDevice
Transcatheter Mitral Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Mi-thos® Transcatheter Mitral Valve Replacement System | Experimental | Transcatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system Receives: Device: Mi-thos® Transcatheter Mitral Valve Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
All of the following must be present:
- Absence of procedural mortality; and II. Successful access, delivery, and retrieval of the device delivery system; and III. Successful deployment and correct positioning of the first intended device; and IV. Freedom from emergency surgery or reintervention related to the device or access procedure
Measured: immediate post-surgical
Secondary outcomes (5)
Rate of all-cause mortality
All-cause mortality after TMVR
Measured: 30 days
Rate of Severe adverse event
Severe adverse events rate after TMVR
Measured: 30 days
Device success
All of the following must be present:
- Absence of procedural mortality or stroke; and II. Proper placement and positioning of the device; and III. Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and
IV. Continued intended safety and performance of the device, including:
- No evidence of structural or functional failure B. No specific device-related technical failure issues and complications C. Significant alterations in mitral valve hemodynamics (MR≤moderate/EOA≥ 1.5 cm2/mean transmitral gradient < 5 mmHg/no paravalvular MR associated hemolysis)
Measured: 30 days
Procedural success
All of the following must be present:
- Device success, and
II. Absence of major device or procedure related serious adverse events, including:
- Death B. Stroke C. Life-threatening bleeding (MVARC scale) D. Major vascular complications E. Major cardiac structural complications F. Stage 2 or 3 acute kidney injury (includes new dialysis) G. Myocardial infarction or coronary ischaemia requiring PCI or CABG H. Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments I. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Measured: 30 days
Incidence of arrhythmia or conduction block
Incidence of arrhythmia or conduction block after TMVR
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start21 Apr 2021
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai NewMed Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784337
- Sponsor's protocol ID
- Mi-thos-FIM
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2023
- Last updated
- 24 Mar 2023
- 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 24 Mar 2023. 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(First-in-Man Study)
- ClinicalTrials.gov ID
- NCT05784337
- Acronym / sponsor ID
- Mi-thos-FIM
- Conditions
- Mitral Valve Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Shanghai NewMed Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 24 Mar 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 evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or who are not candidates for conventional surgery.
Detailed description
The Mi-thos® study is a 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 |
|---|---|---|
| Mi-thos® Transcatheter Mitral Valve Replacement System | Experimental | Device: Mi-thos® Transcatheter Mitral Valve Replacement 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 (5 listed)
- Severe mitral regurgitation ≥ 3+;
- Patients with an STS score >8 or who have been evaluated by a cardiothoracic surgeon as high risk for conventional surgery or who cannot tolerate conventional open-heart surgery;
- Age ≥ 65 years old;
- Life expectancy > 12 months;
- Patients sign an informed consent form.
Key exclusion criteria (19 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® Transcatheter Mitral Valve Replacement SystemTranscatheter Mitral Valve Replacement | Device | Mi-thos® Transcatheter Mitral Valve Replacement System |
Primary outcome
Technical success
Time frame: immediate post-surgical
All of the following must be present: I. Absence of procedural mortality; and II. Successful access, delivery, and retrieval of the device delivery system; and III. Successful deployment and correct positioning of the first intended device; and IV. Freedom from emergency surgery or reintervention related to the device or access procedure
5 secondary outcomes
Rate of all-cause mortality
Time frame: 30 days
Rate of Severe adverse event
Time frame: 30 days
Device success
Time frame: 30 days
Procedural success
Time frame: 30 days
Incidence of arrhythmia or conduction block
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 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® Transcatheter Mitral Valve Replacement System in people with Mitral Valve Regurgitation, run by Shanghai NewMed Medical Co., Ltd. at 2 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 5 inclusion and 19 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: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: immediate post-surgical). 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 24 Mar 2023.