Mitral RegurgitationNCT05655897
Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation
A study testing GeminiOne Transcatheter Valve Edge-to-Edge Repair System in people with Mitral Regurgitation and Degenerative Mitral Valve Disease, 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 GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral 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, Degenerative Mitral Valve Disease
- What is being tested?
- GeminiOne Transcatheter Valve Edge-to-Edge Repair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2022to 24 Nov 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 volunteer to participate and sign an informed consent form, understand the purpose of the clinical trial and are able to cooperate throughout the trial process;
- An age ≥ 18 years;
- Diagnostic transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days to determine the presence of symptomatic moderate-severe or severe degenerative mitral regurgitation (defined as mitral regurgitation grade ≥3+);
- Patients' New York Heart Association (NYHA) cardiac function classification (see Appendix II) in grades II, III, or non-ambulatory grade IV；
- Patients' left ventricular ejection fraction LVEF ≥ 20%;
- Patients considered to be at high surgical risk by the multidisciplinary cardiac team ;
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- Patients are anatomically suitable for mitral valve repair and suitable for the device under this study as assessed by the multidisciplinary cardiac team;
- Elements include, however, are not constrained to the following:
- Mitral valve orifice area ≥ 4.0 cm2;
- Left ventricular end-systolic dimension (LVESD) ≤ 60 mm;
- The primary regurgitant bundle is a non-conjunctive regurgitant bundle and if the secondary regurgitant bundle is present, must be clinically insignificant;
- Transeptal puncture and femoral venipuncture are feasible; The recommended reference criteria for high surgical risk are: an STS score of ≥8 for surgical valve replacement (see Appendix III) or an STS score of ≥6 for surgical valve repair, or the existence of other high-risk factors, such as the presence of other high-risk elements such as the presence of ≥ 2 warning signs of moderate-severe frailty or the presence of feasible surgical operative limitations or the presence of ≥ 2 main organs dysfunctions that cannot be elevated postoperatively or other surgical high-risk factors that are genuinely existing in the judgment of the independent cardiac surgeon in this study.
Who cannot join
- The presence of intra-cardiac space occupancy, thrombus, or bulky organisms as indicated by echocardiography;
- The presence of other severe heart valve diseases requiring surgical intervention;
- Leaflet anatomy that may prevent implantation of the valve clip, proper positioning on the leaflet, or prevent adequate reduction of mitral regurgitation by the valve clip. The assessment is based on transesophageal echocardiographic (TEE) mitral valve evaluation within 180 days prior to the subject's registration and includes:
- inability of the valve clips to hold sufficient active leaflets;
- lack of primary and secondary tendon support in the clamping area;
- significant evidence of calcification in the clamping area;
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- significant fissures in the clamping area;
- Active endocarditis, pericarditis, or rheumatic heart disease; or mitral valve leaflet changes resulting from endocarditis or rheumatic heart disease;
- Severe right ventricular insufficiency (e.g. with symptoms of bilateral lower limb edema with increased jugular venous pressure and hepatomegaly); or pulmonary hypertension (pulmonary artery systolic pressure PASA > 70 mmHg as measured by echocardiography);
- Patients who have had an acute coronary syndrome within 4 weeks, or untreated severe coronary artery stenosis requiring revascularization;
- Patients with any cardiovascular intervention, cardiac surgery, cardiac resynchronization therapy (CRT, CRT-D), implantation of a buried cardioverter-defibrillator (ICD), etc. within 30 days; or have planned one of these procedures;
- Patients underwent mitral valve surgery or mitral transcatheter valve surgery before, or have a left atrial appendage occluder device inside；
- Patients with end-stage heart failure (ACC/AHA stage D), or after cardiac transplantation, or awaiting cardiac transplantation;
- Patients who are hemodynamically unstable, defined as systolic blood pressure <90 mmHg without postload-reducing drugs, or in cardiogenic shock; or are requiring intra-aortic balloon counterpulsation, or other hemodynamic support drugs or devices;
- Patients requiring emergency or urgent surgery for any reason;
- Patients' femoral vein cannot accommodate a 22F catheter or overlaying ipsilateral deep venous thrombosis, as assessed by the investigator, or are anatomically unsuitable for atrial septum puncture; [13
- Patients with active infection requiring concurrent antibiotic treatment; in the case of temporary disease, antibiotics must be discontinued for at least 14 days before enrollment;
- Patients with a history of any cerebrovascular accident within 30 days; or a severe symptomatic carotid stenosis (carotid ultrasound suggesting >70% stenosis);
- Modified Rankin Scale score ≥ 4 (see Annex IV);
- Patients with a history of acute peptic ulcer or gastrointestinal bleeding within 3 months;
- Patients with hematological cachexia, including granulocytopenia (WBC <3 x 109/L), anemia (HB < 90 g/L), thrombocytopenia (PLT <50 x 109/L), bleeding disorders, and coagulopathy; or the presence of contraindications to antiplatelet or anticoagulant medication;
- Patients with a contraindication to transesophageal echocardiography; or a contraindication to general anesthesia；
- Patients with severe chronic obstructive pulmonary disease (COPD) requiring long-term steroids or continuous home oxygen therapy；
- Patients with severe hepatic or renal insufficiency (ALT, AST, creatinine > 2 times the upper limit of normal values)；
- Pregnant or lactating women, or those with a birth plan within 12 months；
- Patients with known hypersensitivity to device components or contrast media；
- Patients enrolled in another clinical study and within the follow-up period；
- Patients with a disease that would make the evaluation of treatment difficult (e.g. cancer, infection, severe metabolic disease, psychiatric disease, etc.); or patients with a life expectancy shorter than 12 months；
- Patients whose compliance is assessed by the investigator to be poor and are unable to comply with the follow-up schedule and complete the examination; or other situations in which the investigator considers the issue to be unsuitable for participation in the study.
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
Jinjin Zhang, +86-13814870113, jameszhang@peijiamedical.com
About this study
Official title: A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System for the Treatment of Moderate-severe or Severe Degenerative Mitral Regurgitation With Single-arm Objective Performance Criteria
To observe and evaluate the safety and efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation through a prospective, multicenter clinical trial using objective performance criteria.
- Being tested
- GeminiOne Transcatheter Valve Edge-to-Edge Repair 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.
GeminiOne Transcatheter Valve Edge-to-Edge Repair SystemDevice
The transcatheter valve clamp system consists of a valve clamp, an adjustable bend mid-tube, and a manipulated inner tube. The adjustable bend introducer catheter consists of an adjustable bend outer tube and dilator. The valve clip is composed of nickel-titanium alloy, cobalt-chromium-nickel-molybdenum-iron alloy, and polyethylene terephthalate material and contains a closure clip, gripping tab, central mechanism, braid, and suture. The adjustable bend guiding catheter is used to provide access to the transcatheter valve clamping system and to reach the designated position. The adjustable curved mid-tube and manipulated inner tube are used to enable the delivery, gripping, and release process of the valve clips within the body.
| Study group | Role | What they receive |
|---|---|---|
| A single set of test | Experimental | The GeminiOne Transcatheter Valve Edge-to-Edge Repair System consists of a transcatheter valve clamping system and an adjustable curved introducer catheter. Receives: Device: GeminiOne Transcatheter Valve Edge-to-Edge Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success
Percentage of patients freedom from: death, surgery for valve dysfunction, and MR > 2+ (moderate to severe (3+) or severe (4+) mitral regurgitation) .
Measured: 12 months
Secondary outcomes (5)
Acute procedural success
Successful in GeminiOne implantation, and residual MR of 2+ or less at discharge. An echocardiography echocardiogram at 30 days can be accepted if the discharge image is not available or hard to interpret. A death before discharge or a re-operation of the mitral valve prior to 30 days is defined as acute procedure failure.
Measured: Immediately after procedure, Discharge: 1 day after the patient's exit from the cardiac catheterization laboratory
Acute device success
Rate of successful delivery and release of one or more GeminiOne devices with echocardiographic confirmation of leaflet clamping and successful withdrawal of the delivery catheter
Measured: Immediately after procedure
Composite of function and re-operation measures
Number of patients freedom from postoperative surgery for mitral valve dysfunction.
Measured: 30 days, 6 months, and 12 months
Cardiac function change
Number of patients with New York Heart Association (NYHA) Function Class I or II.
Measured: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Quality of life improvement
Change in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start24 Nov 2022
- Primary completion24 Nov 2025 (estimated)
- Study completion24 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655897
- Sponsor's protocol ID
- 22CSP001
- Status last verified
- Jun 2024
- First submitted
- 30 Nov 2022
- Last updated
- 5 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu D, Fang Z, Liu X, Zhang N, Liu Y, Wang Y, Ma L, Liu J, Yang J, Li Y, Luo C, Peng X, Zhong W, Chen L, Xu J, Ouyang F, Xiu J, Liu J, He B, Chen M, Zhou S, Pan X. Novel Transcatheter Edge-to-Edge Repair System for Degenerative Mitral Regurgitation: 1-Year Outcomes. JACC Asia. 2026 Jun 5:S2772-3747(26)00270-X. doi: 10.1016/j.jacasi.2026.04.013. Online ahead of print.
PubMed 42283667
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. 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 GeminiOne Transcatheter Valve Edge-to-Edge Repair System for the Treatment of Moderate-severe or Severe Degenerative Mitral Regurgitation With Single-arm Objective Performance Criteria
- ClinicalTrials.gov ID
- NCT05655897
- Acronym / sponsor ID
- 22CSP001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 24 Nov 2025 (estimated)
- Study completion
- 24 Nov 2029 (estimated)
- First posted
- 19 Dec 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 GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral 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: GeminiOne Transcatheter Valve Edge-to-Edge Repair SystemThe GeminiOne Transcatheter Valve Edge-to-Edge Repair System consists of a transcatheter valve clamping system and an adjustable curved introducer catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who volunteer to participate and sign an informed consent form, understand the purpose of the clinical trial and are able to cooperate throughout the trial process;
- An age ≥ 18 years;
- Diagnostic transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days to determine the presence of symptomatic moderate-severe or severe degenerative mitral regurgitation (defined as mitral regurgitation grade ≥3+);
- Patients' New York Heart Association (NYHA) cardiac function classification (see Appendix II) in grades II, III, or non-ambulatory grade IV；
- Patients' left ventricular ejection fraction LVEF ≥ 20%;
Key exclusion criteria (29 listed)
- The presence of intra-cardiac space occupancy, thrombus, or bulky organisms as indicated by echocardiography;
- The presence of other severe heart valve diseases requiring surgical intervention;
- Leaflet anatomy that may prevent implantation of the valve clip, proper positioning on the leaflet, or prevent adequate reduction of mitral regurgitation by the valve clip. The assessment is based on transesophageal echocardiographic (TEE) mitral valve evaluation within 180 days prior to the subject's registration and includes:
- Active endocarditis, pericarditis, or rheumatic heart disease; or mitral valve leaflet changes resulting from endocarditis or rheumatic heart disease;
- Severe right ventricular insufficiency (e.g. with symptoms of bilateral lower limb edema with increased jugular venous pressure and hepatomegaly); or pulmonary hypertension (pulmonary artery systolic pressure PASA > 70 mmHg as measured by echocardiography);
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 |
|---|---|---|
| GeminiOne Transcatheter Valve Edge-to-Edge Repair SystemThe transcatheter valve clamp system consists of a valve clamp, an adjustable bend mid-tube, and a manipulated inner tube. The adjustable bend introducer catheter consists of an adjustable bend outer tube and dilator. The valve clip is composed of nickel-titanium alloy, cobalt-chromium-nickel-molybdenum-iron alloy, and polyethylene terephthalate material and contains a closure clip, gripping tab, central mechanism, braid, and suture. The adjustable bend guiding catheter is used to provide access to the transcatheter valve clamping system and to reach the designated position. The adjustable curved mid-tube and manipulated inner tube are used to enable the delivery, gripping, and release process of the valve clips within the body. | Device | A single set of test |
Primary outcome
Treatment success
Time frame: 12 months
Percentage of patients freedom from: death, surgery for valve dysfunction, and MR > 2+ (moderate to severe (3+) or severe (4+) mitral regurgitation) .
5 secondary outcomes
Acute procedural success
Time frame: Immediately after procedure, Discharge: 1 day after the patient's exit from the cardiac catheterization laboratory
Acute device success
Time frame: Immediately after procedure
Composite of function and re-operation measures
Time frame: 30 days, 6 months, and 12 months
Cardiac function change
Time frame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Quality of life improvement
Time frame: 12 months
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 5 Jun 2024.
- Derived from this study: PubMed 42283667Zhu D, Fang Z, Liu X, Zhang N, Liu Y, Wang Y, Ma L, Liu J, Yang J, Li Y, Luo C, Peng X, Zhong W, Chen L, Xu J, Ouyang F, Xiu J, Liu J, He B, Chen M, Zhou S, Pan X. Novel Transcatheter Edge-to-Edge Repair System for Degenerative Mitral Regurgitation: 1-Year Outcomes. JACC Asia. 2026 Jun 5:S2772-3747(26)00270-X. doi: 10.1016/j.jacasi.2026.04.013. Online ahead of print.
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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 GeminiOne Transcatheter Valve Edge-to-Edge Repair System in people with Mitral Regurgitation and Degenerative Mitral Valve Disease, 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 12 inclusion and 29 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 5 Jun 2024. 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 Jinjin Zhang (+86-13814870113, jameszhang@peijiamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05655897, which also lists 1 linked publication.
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 5 Jun 2024.