Mitral Regurgitation (MR)MITRA-EFSNCT07501234
Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System
A study testing MitraFix® Transcatheter Mitral Valve System in people with Mitral Regurgitation (MR), run by Mitrassist Lifesciences Limited Co., Ltd. at 1 site in China.
Trial summary
The goal of this early feasibility clinical trial is to test a new device called the MitraFix® Transcatheter Mitral Valve System. It aims to learn if the device is safe and if it can help adults who have a severe leaky heart valve (mitral regurgitation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation (MR)
- What is being tested?
- MitraFix® Transcatheter Mitral Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2026to 23 Oct 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe or severe (≥3+) mitral regurgitation.
- Age ≥ 18 years.
- Patients at high risk for traditional open-heart surgery, defined as: STS mortality risk for mitral valve replacement ≥ 8%; OR presence of 2 or more frailty indices; OR presence of 2 or more major organ dysfunctions that cannot be improved post-operatively; OR other comorbidities or factors making them unsuitable for surgery.
- Anatomically suitable for transcatheter MitraFix® system implantation via a transfemoral-transseptal approach as assessed by the investigator; the transfemoral-transseptal access route meets the requirements of the delivery system.
- Able to understand the study purpose, voluntarily participate, sign the informed consent form, and willing to accept relevant examinations and clinical follow-ups.
Who cannot join
- Severe mitral stenosis.
- Severe calcification of mitral leaflets and/or annulus; anatomical structures of the mitral valve apparatus (e.g., papillary muscles) unsuitable for device implantation.
- High risk of left ventricular outflow tract obstruction (LVOTO) based on pre-operative CT/TEE planning (estimated neo-LVOT < 150 mm²), which cannot be avoided by procedural optimization.
- Presence of previous implants in the mitral position (surgical bioprosthetic or mechanical valves, surgical annuloplasty rings, etc.).
- Infective endocarditis or evidence of active infection.
- Stroke or transient ischemic attack (TIA) within 90 days.
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- Severe untreated coronary artery disease or acute myocardial infarction within 90 days; or percutaneous coronary intervention (PCI)/coronary stent implantation within 90 days.
- Severe pulmonary hypertension (resting PASP > 70 mmHg, assessed as irreversible).
- Severe right ventricular dysfunction: Tricuspid Annular Plane Systolic Excursion (TAPSE) < 17 mm.
- Concomitant tricuspid valve, aortic valve, or severe great vessel disease requiring surgical or interventional treatment.
- Left ventricular ejection fraction (LVEF) < 30%.
- Extreme frailty preventing tolerance of the procedure, or in a state of shock requiring circulatory support.
- Implantation of CRT, CRT-D, or implantable cardioverter-defibrillator (ICD) within 30 days.
- Chronic dialysis or expected need for long-term dialysis; or severe renal impairment (e.g., eGFR < 30 mL/min/1.73m²) unable to undergo perioperative dialysis.
- Documented coagulopathy or severe hematological disorders (e.g., platelet count < 50×10^9/L, active bleeding), or history of heparin-induced thrombocytopenia (HIT).
- Contraindications to anticoagulant/antiplatelet therapy that cannot be substituted or bridged.
- Echocardiographic evidence of any intracardiac mass, or thrombus in the left ventricle or left atrium (including left atrial appendage).
- Contraindications to transesophageal echocardiography (TEE).
- Severe allergy to iodine contrast media, nitinol, bovine-derived materials, or other device materials that remains intolerable despite premedication.
- Life expectancy < 12 months.
- Pregnant or breastfeeding women.
- Unsuitable for the transfemoral-transseptal approach (e.g., femoral vein diameter, calcification, tortuosity, or atrial septum/left atrial anatomy not meeting delivery system requirements).
- Participation in another clinical study of an investigational device or drug within 3 months prior to screening that may interfere with this study.
- Any other conditions deemed unsuitable for enrollment by the investigator.
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
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Wang ShouZheng, +86-18721127040, DrWang0229@163.com
Wang Shouzheng
About this study
Official title: A Prospective Clinical Study to Evaluate the Safety and Clinical Feasibility of the MitraFix® Transcatheter Mitral Valve System
The goal of this early feasibility clinical trial is to test a new device called the MitraFix® Transcatheter Mitral Valve System. It aims to learn if the device is safe and if it can help adults who have a severe leaky heart valve (mitral regurgitation). This study is for people who are at high risk for traditional open-heart surgery.
The main questions it aims to answer are:
Read more
Is the MitraFix system safe for participants? Can the device be successfully placed in the heart? Does the device help reduce the valve leak and improve daily life?
Participants will:
Receive the MitraFix valve through a small tube inserted into a vein in the leg.
Visit the clinic for heart tests, walking tests, and health checks for up to one year after the procedure.
- Conditions
- Mitral Regurgitation (MR)
- Being tested
- MitraFix® Transcatheter Mitral Valve System
- Keywords
- MitraFix, Transcatheter Mitral Valve Replacement
- 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.
MitraFix® Transcatheter Mitral Valve SystemDevice
The MitraFix® Transcatheter Mitral Valve System is implanted via a transfemoral-transseptal approach.
| Study group | Role | What they receive |
|---|---|---|
| MitraFix System | Experimental | Participants with moderate-to-severe or severe (≥3+) mitral regurgitation who are at high surgical risk will receive the MitraFix® Transcatheter Mitral Valve System. Receives: Device: MitraFix® Transcatheter Mitral Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Success Rate
evice success is defined as the patient being alive and free from stroke, with the implanted valve in the intended position and functioning properly, without the need for re-operation or re-intervention due to device-related complications.
Measured: 30 days post-procedure
Secondary outcomes (9)
Technical Success Rate
Percentage of participants achieving technical success, defined as successful access, delivery, and deployment of the device, and successful retrieval of the delivery system.
Measured: Intra-operative (At the time of procedure)
Procedural Success Rate
Percentage of participants achieving procedural success, typically defined as technical success without the occurrence of major device- or procedure-related serious adverse events.
Measured: 30 days post-procedure
Valve Performance Assessment
Evaluated by echocardiography, including the severity of residual mitral regurgitation, transvalvular pressure gradient, and the presence/severity of paravalvular leak.
Measured: Up to 12 months post-procedure
Change in New York Heart Association (NYHA) Functional Class
Assessment of clinical improvement in heart failure symptoms based on the NYHA classification (Class I to IV, where a lower class indicates better function).
Measured: Up to 12 months post-procedure
Change in Quality of Life Assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Quality of life is evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ Overall Summary Score ranges from 0 to 100. Higher scores indicate fewer symptoms and better health-related quality of life.
Measured: Up to 12 months post-procedure
Change in 6-Minute Walk Distance
The change in the total distance (in meters) a participant can walk on a flat surface in 6 minutes, used to evaluate exercise capacity.
Measured: Up to 12 months post-procedure
Rate of Hospitalization for Heart Failure
Number of participants requiring hospital admission or an emergency/urgent care visit for the treatment of worsening heart failure.
Measured: Up to 12 months post-procedure
Incidence of Major Adverse Events (MAEs)
Number of participants experiencing major adverse events, such as all-cause mortality, stroke, life-threatening bleeding, or acute kidney injury.
Measured: Up to 12 months post-procedure
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants experiencing any device-related or procedure-related adverse events and serious adverse events.
Measured: Up to 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start23 Mar 2026 (estimated)
- Primary completion23 Mar 2028 (estimated)
- Study completion23 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Regurgitation (MR)Studies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mitrassist Lifesciences Limited Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501234
- Sponsor's protocol ID
- TF-TMVR-EFS-01
- Acronym
- MITRA-EFS
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study to Evaluate the Safety and Clinical Feasibility of the MitraFix® Transcatheter Mitral Valve System
- ClinicalTrials.gov ID
- NCT07501234
- Acronym / sponsor ID
- MITRA-EFS / TF-TMVR-EFS-01
- Conditions
- Mitral Regurgitation (MR)
- Keywords
- MitraFix, Transcatheter Mitral Valve Replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Mitrassist Lifesciences Limited Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2026 (estimated)
- Primary completion
- 23 Mar 2028 (estimated)
- Study completion
- 23 Oct 2028 (estimated)
- First posted
- 30 Mar 2026 (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 goal of this early feasibility clinical trial is to test a new device called the MitraFix® Transcatheter Mitral Valve System. It aims to learn if the device is safe and if it can help adults who have a severe leaky heart valve (mitral regurgitation). This study is for people who are at high risk for traditional open-heart surgery.
The main questions it aims to answer are:
Is the MitraFix system safe for participants? Can the device be successfully placed in the heart? Does the device help reduce the valve leak and improve daily life?
Participants will:
Receive the MitraFix valve through a small tube inserted into a vein in the leg.
Visit the clinic for heart tests, walking tests, and health checks for up to one year after the procedure.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MitraFix System | Experimental | Device: MitraFix® Transcatheter Mitral Valve SystemParticipants with moderate-to-severe or severe (≥3+) mitral regurgitation who are at high surgical risk will receive the MitraFix® Transcatheter Mitral Valve System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Moderate to severe or severe (≥3+) mitral regurgitation.
- Age ≥ 18 years.
- Patients at high risk for traditional open-heart surgery, defined as: STS mortality risk for mitral valve replacement ≥ 8%; OR presence of 2 or more frailty indices; OR presence of 2 or more major organ dysfunctions that cannot be improved post-operatively; OR other comorbidities or factors making them unsuitable for surgery.
- Anatomically suitable for transcatheter MitraFix® system implantation via a transfemoral-transseptal approach as assessed by the investigator; the transfemoral-transseptal access route meets the requirements of the delivery system.
- Able to understand the study purpose, voluntarily participate, sign the informed consent form, and willing to accept relevant examinations and clinical follow-ups.
Key exclusion criteria (24 listed)
- Severe mitral stenosis.
- Severe calcification of mitral leaflets and/or annulus; anatomical structures of the mitral valve apparatus (e.g., papillary muscles) unsuitable for device implantation.
- High risk of left ventricular outflow tract obstruction (LVOTO) based on pre-operative CT/TEE planning (estimated neo-LVOT < 150 mm²), which cannot be avoided by procedural optimization.
- Presence of previous implants in the mitral position (surgical bioprosthetic or mechanical valves, surgical annuloplasty rings, etc.).
- Infective endocarditis or evidence of active infection.
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 |
|---|---|---|
| MitraFix® Transcatheter Mitral Valve SystemThe MitraFix® Transcatheter Mitral Valve System is implanted via a transfemoral-transseptal approach. | Device | MitraFix System |
Primary outcome
Device Success Rate
Time frame: 30 days post-procedure
evice success is defined as the patient being alive and free from stroke, with the implanted valve in the intended position and functioning properly, without the need for re-operation or re-intervention due to device-related complications.
9 secondary outcomes
Technical Success Rate
Time frame: Intra-operative (At the time of procedure)
Procedural Success Rate
Time frame: 30 days post-procedure
Valve Performance Assessment
Time frame: Up to 12 months post-procedure
Change in New York Heart Association (NYHA) Functional Class
Time frame: Up to 12 months post-procedure
Change in Quality of Life Assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time frame: Up to 12 months post-procedure
Change in 6-Minute Walk Distance
Time frame: Up to 12 months post-procedure
Rate of Hospitalization for Heart Failure
Time frame: Up to 12 months post-procedure
Incidence of Major Adverse Events (MAEs)
Time frame: Up to 12 months post-procedure
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 12 months post-procedure
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 30 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MitraFix® Transcatheter Mitral Valve System in people with Mitral Regurgitation (MR), run by Mitrassist Lifesciences Limited 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 5 inclusion and 24 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 30 Mar 2026. 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 NaXin Di (021-69925338, tina.ti@mitrassist.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Success Rate (time frame: 30 days post-procedure). 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 30 Mar 2026.