Mitral RegurgitationNCT05610566
Safety and Efficacy of the HighLife Transcatherter Mitral Valve Replacement System in Patients With Moderate-severe or Severe Mitral Regurgitation in China
A study testing the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System in people with Mitral Regurgitation, run by Peijia Medical Technology (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2022to 6 Jul 2029
- 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
- Patients who voluntarily participate and sign the informed consent form and can cooperate with the completion of the entire trial process;
- Age ≥ 18 years old;
- Moderate-severe or severe mitral regurgitation (≥3+); Note 1: Patients with ischemic or non-ischemic heart disease induced symptomatic secondary mitral regurgitation as the primary cause must be treated for at least 1 month after optimal guideline medical therapy (GDMT). Echocardiography should be performed 3 months after cardiac resynchronization therapy and 1 month after coronary revascularization to assess the degree of regurgitation.
- Note 2: For patients with primary mitral regurgitation, the multidisciplinary cardiac team of the research center needs to use a standard scoring system, considering multiple factors such as complications, frailty, and disability, ensuring the enrolled with a high risk of surgery.
- Patients with New York Heart Association (NYHA) functional ratings are Class II, III, or ambulatory Class IV;
- Anatomically appropriate for treatment with the HighLife Transcatheter Mitral Valve Replacement System.
Who cannot join
- Patients had any stroke/TIA within 30 days;
- Patients with severe symptomatic bilateral carotid stenosis (>70% stenosis on non-invasive imaging);
- Patients with active infection requiring antibiotic therapy;
- Patients with active ulcer or gastrointestinal bleeding within the past 3 months;
- Patients with history of coagulopathy or refuse future blood transfusion;
- Patients unable to undergo transesophageal echocardiography (TEE);
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- Patients who are pregnant or breastfeeding, or planning to have children within 12 months;
- Patients who are unable to adhere to the follow-up schedule and complete the examination;
- Patients enrolled in other clinical studies and within the follow-up period;
- Patients with known allergies to device components or contrast agents;
- Patients unable to receive anticoagulant or antiplatelet therapy;
- Patients with a life expectancy of less than 12 months due to non-cardiac disease;
- Patients requiring emergency surgical treatment;
- Patients scheduled for cardiac surgery within 12 months;
- Patients with an inappropriate mitral annulus or leaflet size (<30 mm and >45 mm);
- Patients with moderate or above mitral stenosis;
- Flail mitral leaflets, or moderate to severe mitral valve prolapse;
- Patients with severe hepatic or renal insufficiency;
- Patients with severe calcification of the mitral annulus and/or mitral leaflets;
- Patients with history of mitral valve surgery or interventional therapy, or left atrial appendage occlusion device;
- Patients had acute myocardial infarction (MI) (Q-wave MI, or non-Q-wave MI, with CK-MB twice the normal and/or T-MB) within the past 1 month;
- Patients with untreated symptomatic coronary lesions requiring revascularization;
- Patients with untreated severe aortic stenosis and severe aortic regurgitation;
- Patients with aortic valve prosthesis;
- Patients with severe tricuspid valve lesions requiring surgical intervention;
- Patients with significant right ventricular dysfunction (such as biliteral lower extremities edema with increased jugular vein pulsation and hepatomegaly;
- LVEF < 30%; LVEDD > 70 mm;
- Patients with echocardiographically confirmed intracardiac mass, thrombus or neoplasm;
- Hypertrophic obstructive cardiomyopathy (HOCM);
- Patients with active or recent (within 3 months) endocarditis;
- Patients with definite non-left heart disease induced severe pulmonary hypertension (echocardiographic indication: systolic pulmonary artery pressure (SPAP) > 70 mmHg)
- Patients with hypotension (systolic blood pressure <90 mmHg) occurring within 7 days or mechanical hemodynamic support.
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
Peiga Medical Technology (Suzhou) Co.
Suzhou, Jiangsu, 215025
Kejing Yi, +86-13801858760, yikejing@peijiamedical.com
About this study
Official title: A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System for the Treatment of Moderate-severe or Severe Mitral Regurgitation With Single-arm Objective Performance Criteria
To observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria.
- Conditions
- Mitral Regurgitation
- Being tested
- the HighLife Trans-Septal 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.
the HighLife Trans-Septal Transcatheter Mitral Valve Replacement SystemDevice
The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a subannular implant (SAI), and their delivery systems and accessories. The TMV is a 28mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around the mitral valve apparatus to stabilize the position of the mitral valve implant.
| Study group | Role | What they receive |
|---|---|---|
| A single set of test | Experimental | The HighLife Trans-Septal TMVR System comprises a 28mm Transcatheter Mitral Valve, a loop placement catheter, a sub-annular implant and its delivery systems. Receives: Device: the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at 12 months
All-cause mortality
Measured: 12 months
Secondary outcomes (3)
Technical success
Technical success defined as an alive patient at exit from procedure room, with all of the following:
- Successful vascular access, delivery and retrieval of the HighLife delivery systems
- Deployment and correct positioning of the HighLife 28mm bioprosthesis
- Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE.
Measured: Immediate after procedure
Cardiac function change
NYHA functional classification
Measured: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Quality of life of patients
Quality of Life of patients accessed by EuroQol-5 Dimensions (EQ-5D) Questionnaire. The higher scores mean a worse health state. Recording changes from baseline.
Measured: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start6 Jul 2022
- Primary completion6 Jul 2025 (estimated)
- Study completion6 Jul 2029 (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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, The Second Affiliated Hospital of Harbin Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610566
- Sponsor's protocol ID
- 23CSP001
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System for the Treatment of Moderate-severe or Severe Mitral Regurgitation With Single-arm Objective Performance Criteria
- ClinicalTrials.gov ID
- NCT05610566
- Acronym / sponsor ID
- 23CSP001
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- West China Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, The Second Affiliated Hospital of Harbin Medical University
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 6 Jul 2025 (estimated)
- Study completion
- 6 Jul 2029 (estimated)
- First posted
- 9 Nov 2022 (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 observe and evaluate the safety and efficacy of the HighLife Transcatheter Mitral Valve Replacement System in patients with moderate-severe or severe mitral valve regurgitation through a prospective, multicenter clinical trial using objective performance criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single set of test | Experimental | Device: the HighLife Trans-Septal Transcatheter Mitral Valve Replacement SystemThe HighLife Trans-Septal TMVR System comprises a 28mm Transcatheter Mitral Valve, a loop placement catheter, a sub-annular implant and its delivery systems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who voluntarily participate and sign the informed consent form and can cooperate with the completion of the entire trial process;
- Age ≥ 18 years old;
- Moderate-severe or severe mitral regurgitation (≥3+); Note 1: Patients with ischemic or non-ischemic heart disease induced symptomatic secondary mitral regurgitation as the primary cause must be treated for at least 1 month after optimal guideline medical therapy (GDMT). Echocardiography should be performed 3 months after cardiac resynchronization therapy and 1 month after coronary revascularization to assess the degree of regurgitation.
- Note 2: For patients with primary mitral regurgitation, the multidisciplinary cardiac team of the research center needs to use a standard scoring system, considering multiple factors such as complications, frailty, and disability, ensuring the enrolled with a high risk of surgery.
- Patients with New York Heart Association (NYHA) functional ratings are Class II, III, or ambulatory Class IV;
Key exclusion criteria (32 listed)
- Patients had any stroke/TIA within 30 days;
- Patients with severe symptomatic bilateral carotid stenosis (>70% stenosis on non-invasive imaging);
- Patients with active infection requiring antibiotic therapy;
- Patients with active ulcer or gastrointestinal bleeding within the past 3 months;
- Patients with history of coagulopathy or refuse future blood transfusion;
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 |
|---|---|---|
| the HighLife Trans-Septal Transcatheter Mitral Valve Replacement SystemThe HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a subannular implant (SAI), and their delivery systems and accessories. The TMV is a 28mm mitral bioprosthesis made of a self-expanding Nitinol frame covered with polyester graft and supporting bovine pericardium leaflets. The bioprosthesis is used in conjunction with the Sub-Annular Implant (SAI), comprising a ring (made of polycarbonate urethane (PCU), nitinol, gold markers and polyester (Dacron) to be placed around the mitral valve apparatus to stabilize the position of the mitral valve implant. | Device | A single set of test |
Primary outcome
All-cause mortality at 12 months
Time frame: 12 months
All-cause mortality
3 secondary outcomes
Technical success
Time frame: Immediate after procedure
Cardiac function change
Time frame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Quality of life of patients
Time frame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 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 9 Nov 2022.
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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 the HighLife Trans-Septal Transcatheter Mitral Valve Replacement System in people with Mitral Regurgitation, run by Peijia Medical Technology (Suzhou) 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 6 inclusion and 32 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 Nov 2022. 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 Kejing Yi (+86-13801858760, yikejing@peijiamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at 12 months (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 9 Nov 2022.