Mitral RNCT07055919
Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).
A study testing Structural Heart Surgery Assist System and Manual MitraClip G4 in people with Mitral R and Mitral Regurgitation, run by Xiamen Cardiovascular Hospital, Xiamen University at 1 site in China.
Trial summary
This trial aims to evaluate the safety and efficacy of the Structural Heart Surgery Assist System in assisting TEER for patients with moderate-to-severe or greater degenerative or functional mitral regurgitation (MR ≥3+). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral R, Mitral Regurgitation
- What is being tested?
- Structural Heart Surgery Assist System and Manual MitraClip G4
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2025to 22 Apr 2026
- 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
- Age ≥18 years, regardless of gender.
- Symptomatic moderate-to-severe or greater mitral regurgitation (MR ≥3+) confirmed by transthoracic and/or transesophageal echocardiography (TTE/TEE), with planned transcatheter edge-to-edge repair (TEER):
- For degenerative mitral regurgitation (DMR):
- -Deemed high-risk for surgical intervention by the heart team:STS score ≥8% for mitral valve replacement (MVR) mortality risk; ≥6% for mitral valve repair mortality risk; OR presence of ≥2 frailty indices (moderate-to-severe frailty); OR anatomical/technical barriers to surgery; OR ≥2 major organ dysfunctions unlikely to improve postoperatively; OR other high-risk factors per heart team assessment.OR patient declines surgery.
- For functional mitral regurgitation (FMR):
- Persistent heart failure symptoms (NYHA Class III/IVa) despite guidelines directed medical therapy (GDMT), revascularization, or cardiac resynchronization therapy (CRT) for 1-3 months.
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- ≥1 hospitalization for heart failure within the past 12 months and/or BNP >150 pg/mL or NT-proBNP >600 pg/mL.
- Left ventricular ejection fraction (LVEF) ≥20% and ≤50%, with left ventricular end-systolic diameter (LVESD) ≤70 mm.
- Primary regurgitant jet is non-commissural and deemed treatable by the investigator (secondary jets, if present, must be clinically insignificant).
- Volunteerly provides informed consent, understands the trial objectives, and agrees to comply with follow-up.
Who cannot join
- Rheumatic mitral valve disease.
- Uncorrected active infection.
- Severe calcification or thickening in the clip coaptation zone, rendering TEER anatomically unsuitable.
- Intracardiac mass, thrombus, or vegetation on echocardiography.
- Severe right heart dysfunction (e.g., lower extremity edema with elevated jugular venous pressure and hepatomegaly) or severe pulmonary hypertension (echocardiographic systolic pulmonary artery pressure >70 mmHg).
- Severe left heart dysfunction (LVEF <20%).
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- Acute myocardial infarction (AMI) within 30 days prior to the procedure.
- Recent CABG, PCI, or TAVR within 30 days prior to the procedure.
- Planned tricuspid/aortic valve or major vascular intervention within 30 days post-procedure.
- Prior surgical or transcatheter mitral valve repair/replacement.
- Thrombosis in access vessels (e.g., femoral vein, inferior vena cava) impeding catheter advancement.
- Stroke/TIA within 30 days or severe carotid stenosis (>70% by ultrasound).
- Cardiomyopathies or conditions including hypertrophic, restrictive, or infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis), constrictive pericarditis, or active endocarditis.
- Hemodynamic instability: Systolic blood pressure <90 mmHg without afterload-reducing agents, cardiogenic shock, requirement for intra-aortic balloon pump (IABP) or hemodynamic support.
- Implanted pacemaker, CRT, or ICD within 30 days prior to the procedure.
- End-stage heart failure (ACC/AHA Stage D), post-heart transplant, or listed for transplant.
- Hypersensitivity or contraindications: ntolerance to anticoagulants, antiplatelet agents, or anesthesia, allergy to mitralclip materials (nickel/titanium, cobalt, chromium, polyester), severe contrast allergy precludes intervention.
- Pregnant or breastfeeding.
- Participation in other clinical trials (drug/device) without meeting primary endpoints.
- Other contraindications per investigator judgment.
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
Structural Heart Disease Unit, Xiamen Cardiovacular Hospital
Xiamen, Fujian, 361000
Yan Wang, Dr, 0592-2293077, wy@medmail.com.cn
Xiang Chen, Dr, 18033997788, seanchenx@126.com
About this study
Official title: A Prospective, Multicenter, Stratified Randomized Controlled, Non-Inferiority Clinical Trial to Evaluate the Safety and Efficacy of the Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).
This trial aims to evaluate the safety and efficacy of the Structural Heart Surgery Assist System in assisting TEER for patients with moderate-to-severe or greater degenerative or functional mitral regurgitation (MR ≥3+). A prospective, multicenter, stratified randomized controlled design with non-inferiority comparison will be used. The experimental group will utilize the Structural Heart Surgery Assist System, while the control group will undergo manual TEER (e.g., MitraClip G4).
- Conditions
- Mitral R, Mitral Regurgitation
- Being tested
- Structural Heart Surgery Assist System, Manual MitraClip G4
- 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.
Structural Heart Surgery Assist SystemDevice
Following femoral venous access and transseptal puncture, the steerable guide catheter and transcatheter mitral valve clip system are inserted and mounted onto the Structural Heart Surgery Assist System. The surgeon manipulates the joystick and controls on the operator console, guided by real-time animations on the human-machine interface that confirm the direction and range of device motion. Under fluoroscopic (DSA) and echocardiographic guidance, the system assists in performing edge-to-edge mitral valve repair. The procedure achieves regurgitation reduction by either creating a double-orifice configuration (A2/P2 segments) or approximating the opposing leaflets at the A1/P1 or A3/P3 regions.
Manual MitraClip G4Device
Manual MitraClip G4
| Study group | Role | What they receive |
|---|---|---|
| Structural Heart Surgery Assist System-assisted TEER. | Experimental | Not described Receives: Device: Structural Heart Surgery Assist System |
| Manual TEER (e.g., MitraClip G4). | Placebo comparator | Not described Receives: Device: Manual MitraClip G4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Success Rate
All of the following conditions need to be met
- Successful implantation of 1 or more mitral clips (successful delivery and release of mitral clips with echocardiographic confirmation of leaflet clamping and successful withdrawal of the transcatheter mitral clip delivery system and manoeuvrable guide catheter);
- Transthoracic echocardiography showing a degree of mitral regurgitation ≤2+ (as evaluated by a third-party core laboratory) prior to discharge (up to 7 days).
Calculation formula: Surgical success rate (%) = (number of cases achieving surgical success in each group/total number of cases in each group) × 100% for each group
Measured: 7days
Secondary outcomes (7)
Instrumental technique success (trial group only)
Definition: Successful completion of transcatheter mitral valve edge-to-edge repair (TEER) using the Structural Heart Surgery Assist System without unplanned manual intervention.
Unplanned Manual Intervention: Defined as conversion to manual operation during stages that the system is designed to assist (clip delivery and leaflet capture), per the Instructions for Use of the Structural Heart Surgery Assist System.
Calculation formula: Instrumental technique success (%) = (number of cases achieving Instrumental technique success in trial group/total number of cases in trial group) × 100% for each group
Measured: Perioperative/Periprocedural
Clinical Success Rate
Criteria (all must be met):
- No intraoperative mortality related to the procedure.
- Successful delivery and deployment of the mitral valve clip, with retrieval of the transcatheter clip delivery system and steerable guide catheter.
- Placement of ≥1 mitral valve clip in the anatomically correct position.
- No unplanned surgeries or reinterventions related to the device or access site prior to discharge (within 7 days maximum).
Calculation formula: Clinical Success Rate (%) = (number of cases achieving Clinical Success in each group/total number of cases in each group) × 100% for each group
Measured: 7days
Change in Mitral Regurgitation (MR) Severity
Assessed by comparing baseline Mitral Regurgitation (MR) Severity 7days and 30 days post-procedure.
The severity of mitral regurgitation was classified as absent (0+), mild (1+), moderate (2+), moderately severe (3+), and severe (4+).
Evaluation method: based on transthoracic echocardiography results.
Measured: 7days/30days
Change in NYHA Functional Class
Assessed by comparing baseline NYHA class to class at 30 days post-procedure.
Measured: 30days
Mitral Clip Implantation Time
Definition: Time from transseptal puncture initiation to successful withdrawal of the steerable guide catheter.
Measured: Perioperative/Periprocedural
Fluoroscopy Time
Recorded using digital subtraction angiography (DSA) and defined as the cumulative X-ray exposure time from procedure start (defined as the first of: vascular access, anesthesia induction, or transesophageal echocardiography [TEE] probe insertion) to successful withdrawal of the steerable guide catheter.
Measured: Perioperative/Periprocedural
Operator Radiation Exposure
Measured using radiation dosimeters worn by the operator, recording cumulative radiation dose from procedure start to guide catheter withdrawal
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start22 Mar 2025
- Primary completion22 Mar 2026 (estimated)
- Study completion22 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Wang, Xiamen Cardiovascular Hospital, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055919
- Sponsor's protocol ID
- QX2025-001-02
- Other IDs
- Beijing Jiekai Cardiovascular
- Status last verified
- Jul 2025
- First submitted
- 14 Mar 2025
- Last updated
- 9 Jul 2025
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Stratified Randomized Controlled, Non-Inferiority Clinical Trial to Evaluate the Safety and Efficacy of the Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).
- ClinicalTrials.gov ID
- NCT07055919
- Acronym / sponsor ID
- QX2025-001-02
- Conditions
- Mitral R, Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen UniversityUniversity, hospital or other
- Study start
- 22 Mar 2025 (actual)
- Primary completion
- 22 Mar 2026 (estimated)
- Study completion
- 22 Apr 2026 (estimated)
- First posted
- 9 Jul 2025 (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.
This trial aims to evaluate the safety and efficacy of the Structural Heart Surgery Assist System in assisting TEER for patients with moderate-to-severe or greater degenerative or functional mitral regurgitation (MR ≥3+). A prospective, multicenter, stratified randomized controlled design with non-inferiority comparison will be used. The experimental group will utilize the Structural Heart Surgery Assist System, while the control group will undergo manual TEER (e.g., MitraClip G4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structural Heart Surgery Assist System-assisted TEER. | Experimental | Device: Structural Heart Surgery Assist System |
| Manual TEER (e.g., MitraClip G4). | Placebo comparator | Device: Manual MitraClip G4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years, regardless of gender.
- Symptomatic moderate-to-severe or greater mitral regurgitation (MR ≥3+) confirmed by transthoracic and/or transesophageal echocardiography (TTE/TEE), with planned transcatheter edge-to-edge repair (TEER):
- -Deemed high-risk for surgical intervention by the heart team:STS score ≥8% for mitral valve replacement (MVR) mortality risk; ≥6% for mitral valve repair mortality risk; OR presence of ≥2 frailty indices (moderate-to-severe frailty); OR anatomical/technical barriers to surgery; OR ≥2 major organ dysfunctions unlikely to improve postoperatively; OR other high-risk factors per heart team assessment.OR patient declines surgery.
- Primary regurgitant jet is non-commissural and deemed treatable by the investigator (secondary jets, if present, must be clinically insignificant).
- Volunteerly provides informed consent, understands the trial objectives, and agrees to comply with follow-up.
Key exclusion criteria (20 listed)
- Rheumatic mitral valve disease.
- Uncorrected active infection.
- Severe calcification or thickening in the clip coaptation zone, rendering TEER anatomically unsuitable.
- Intracardiac mass, thrombus, or vegetation on echocardiography.
- Severe right heart dysfunction (e.g., lower extremity edema with elevated jugular venous pressure and hepatomegaly) or severe pulmonary hypertension (echocardiographic systolic pulmonary artery pressure >70 mmHg).
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 |
|---|---|---|
| Structural Heart Surgery Assist SystemFollowing femoral venous access and transseptal puncture, the steerable guide catheter and transcatheter mitral valve clip system are inserted and mounted onto the Structural Heart Surgery Assist System. The surgeon manipulates the joystick and controls on the operator console, guided by real-time animations on the human-machine interface that confirm the direction and range of device motion. Under fluoroscopic (DSA) and echocardiographic guidance, the system assists in performing edge-to-edge mitral valve repair. The procedure achieves regurgitation reduction by either creating a double-orifice configuration (A2/P2 segments) or approximating the opposing leaflets at the A1/P1 or A3/P3 regions. | Device | Structural Heart Surgery Assist System-assisted TEER. |
| Manual MitraClip G4Manual MitraClip G4 | Device | Manual TEER (e.g., MitraClip G4). |
Primary outcome
Surgical Success Rate
Time frame: 7days
All of the following conditions need to be met 1. Successful implantation of 1 or more mitral clips (successful delivery and release of mitral clips with echocardiographic confirmation of leaflet clamping and successful withdrawal of the transcatheter mitral clip delivery system and manoeuvrable guide catheter); 2. Transthoracic echocardiography showing a degree of mitral regurgitation ≤2+ (as evaluated by a third-party core laboratory) prior to discharge (up to 7 days). Calculation formula: Surgical success rate (%) = (number of cases achieving surgical success in each group/total number of cases in each group) × 100% for each group
7 secondary outcomes
Instrumental technique success (trial group only)
Time frame: Perioperative/Periprocedural
Clinical Success Rate
Time frame: 7days
Change in Mitral Regurgitation (MR) Severity
Time frame: 7days/30days
Change in NYHA Functional Class
Time frame: 30days
Mitral Clip Implantation Time
Time frame: Perioperative/Periprocedural
Fluoroscopy Time
Time frame: Perioperative/Periprocedural
Operator Radiation Exposure
Time frame: Perioperative/Periprocedural
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 9 Jul 2025.
- Individual participant dataSharing planned: No
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Mitral Regurgitation
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 Structural Heart Surgery Assist System and Manual MitraClip G4 in people with Mitral R and Mitral Regurgitation, run by Xiamen Cardiovascular Hospital, Xiamen 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?
The sponsor lists 10 inclusion and 20 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 9 Jul 2025. 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. Some participants in this study may receive a placebo. 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 Xiang Chen, Dr (18033997788, seanchenx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Success Rate (time frame: 7days). 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 9 Jul 2025.