Severe Aortic StenosisTAVINCT03788590
Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
A study testing Jenscare TAVI in people with Severe Aortic Stenosis and Aortic Regurgitation, run by Ningbo Jenscare Biotechnology Co., Ltd..
Trial summary
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or insufficiency patients who are high risk or ineligible for aortic valve replacement. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Severe Aortic Stenosis, Aortic Regurgitation
- What is being tested?
- Jenscare TAVI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- No sites listed yet
- Study dates
- 23 Feb 2019to 30 Dec 2021
- 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
- Subjects ≥ 65 years of age;
- Severe aortic stenosis, as defined by ultrasonic cardiogram (peak velocity ≥4.0 m/s, or mean transaortic systolic pressure gradient ≥40 mmHg, or an aortic valve area of <1.0 cm2) or combined merger; severe aortic insufficiency (regurgitation ≥+++ or regurgitation area ≥0.3cm2) combined with left ventricular dilatation ( LVESD≥50mm or LVEDD≥65mm);or severe aortic valve insufficiency combined with left ventricular systolic dysfunction (LVEF<50%);
- Symptoms suggestive of aortic stenosis, NYHA class III or IV;
- Patients who are considered unsuitable for surgery are considered by two or more than two cardiovascular specialists (≥6% using Society of Thoracic Surgeons scoring system estimation; or there is a severe and irreversible organ damage to the patient, such as lung disease, liver disease, kidney disease and so on; or the patient's physical weakness can not be tolerated by surgery; or have other factors affecting surgery, such as postoperative chest radiosurgery, thoracic deformity, and diffuse severe calcification of the aorta, etc);
- A life expectancy of > 1 year;
- Voluntarily participate in and sign the informed consent form and willing to undergo the related examination and clinical follow-up.
Who cannot join
- Untreated severe coronary stenosis and needs revascularization; or acute myocardial infarction occurred within 1 months, or coronary stent implantation in 1 month;
- Artificial heart valve and artificial valve ring have been implanted；
- Severe mitral insufficiency (regurgitation ≥+++) or mitral stenosis (valvular area<1.5 cm2)；
- left ventricular or atrial thrombus;
- Aortic annulus diameter <17mm or >27 mm;
- Severe left ventricular dysfunction, ejection fraction <20%；
Show all 18Show fewer
- Severe pulmonary hypertension or severe right ventricular dysfunction；
- The ascending aortic ≥5cm or Aortic root diameter ≥4.5cm;
- Cerebrovascular event in last 3 months；
- Active endocarditis or other active infection;
- Severe renal failure and requires long-term dialysis treatment；
- Severe liver dysfunction；
- Active peptic ulcer；
- Severe coagulation dysfunction; it is known that all anticoagulant schemes are taboo or allergic, or anticoagulants can not be used in the process of testing；
- Severe respiratory failure；
- Severe Alzheimer's disease；
- Patients who were enrolled in any other study in one month;
- Other cases which the researchers believe that it is not suitable to participate in.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter, Single-armed Trial That Aims to Evaluate the Safety and Efficacy of Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
The purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or insufficiency patients who are high risk or ineligible for aortic valve replacement.
Read the detailed description
Aortic valve diseases is usually caused by rheumatic fever, congenital aortic valve structural abnormality or degenerative aortic valve calcification. Transcatheter aortic valve implantation (TAVI) has evolved as an alternative to surgical aortic valve replacement (SAVR) with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis, who were considered to be at very high or prohibitive operative risk.
This project take the incidence of all-cause mortality at 12 months since TAVI as the primary endpoint to evaluate the safety and efficacy, then take the procedure success rate, device success rate, incidence of severe adverse events, device operative performance, prosthetic valve performance and quality of life to evaluate transcatheter artificial aortic valve and transcatheter artificial heart values delivery system of Ningbo Jenscare Biotechnology Co., Ltd. in clinical application.
- Conditions
- Severe Aortic Stenosis, Aortic Regurgitation
- Being tested
- Jenscare TAVI
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jenscare TAVIDevice
Jenscare TAVI and delivery system will implant a percutaneous bioprosthesis value, which is positioned in the native aortic valve, plays a role to control blood flow, and help your heart to work better. It may also shorten your recovery time to getting back to everyday activities.
| Study group | Role | What they receive |
|---|---|---|
| Jenscare TAVI | Experimental | Patients undergoing a Jenscare TAVI and delivery system Receives: Device: Jenscare TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Cumulative incidence of a combination of all cause death at 12 month after TAVI
Measured: 12 month
Secondary outcomes (10)
Procedure success rate
Documentation of no death occurred during or within 72 hours after TAVI, no conversion to conventional cardiopulmonary bypass, the value was placed in the correct anatomical position and achieve the desired effect
Measured: During the TAVI procedure
Device success rate
Documentation of the device was implanted successfully, placed in the correct anatomical position and achieve the desired effect
Measured: During the TAVI procedure
Incidence of severe adverse events
Documentation of the serious long-term complications, including mortality, stroke, transient ischemic stroke, myocardial infarction, dialysis and reinterventions
Measured: During the TAVI procedure and 3 days,7 days, 30 days, 3 months, 6 months, 12 months after TAVI
Assessment of device operative performance
Using the following measure (loading and releasing properties of artificial aortic valve; pushing, emptying, withdrawing, developing performance, fracture of the delivery system) that can be converted to utilities using an algorithm. Utilities range from 1 to 3, with 3 representing perfect performance, and 1 corresponding to the worst performance state.
Measured: During the TAVI procedure
Echocardiographic assessment of valve performance
Using the following measures: effective orifice area (EOA)
Measured: 30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance
Using the following measures: transvalvular mean gradient
Measured: 30 days, 3 months, 6 months, 12 months after TAVI
Evaluation and improvement of quality of life
Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.
Measured: Preoperative and 30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance
Using the following measures: peak flow velocity
Measured: 30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance
Using the following measures: degree of aortic valve regurgitation
Measured: 30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance
Using the following measures: degree of perivalvular leakage
Measured: 30 days, 3 months, 6 months, 12 months after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start23 Feb 2019 (estimated)
- Primary completion23 Nov 2021 (estimated)
- Study completion30 Dec 2021 (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 Severe Aortic StenosisStudies 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
- 133 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Jenscare Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peng Cao, Doctor, Study director, Ningbo Jenscare Biotechnology Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788590
- Sponsor's protocol ID
- LT-2017-01
- Acronym
- TAVI
- Status last verified
- Dec 2018
- First submitted
- 21 Dec 2018
- Last updated
- 8 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xiao B, Li M, Liu L, Shi J, Zhang H, Meng X, Chen L, Zhang X, Ma L, Dong N, Shang X, Yang J, Liu Y, Wang P, Xiao Y, Pan X, Wang J, Zhu D, Guo H, Liu J, Wang D, Xu Z, Song Z, Guo Y. Transapical Transcatheter Valve Implantation for Aortic Regurgitation: A Multicentre, Prospective Trial. Eur J Cardiothorac Surg. 2026 Aug 3;68(8):ezag065. doi: 10.1093/ejcts/ezag065.
PubMed 42087322
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-armed Trial That Aims to Evaluate the Safety and Efficacy of Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System
- ClinicalTrials.gov ID
- NCT03788590
- Acronym / sponsor ID
- TAVI / LT-2017-01
- Conditions
- Severe Aortic Stenosis, Aortic Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 133 participants (estimated)
- Lead sponsor
- Ningbo Jenscare Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2019 (estimated)
- Primary completion
- 23 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 27 Dec 2018 (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 purpose of this study is to demonstrate that transcatheter artificial aortic valve and transcatheter artificial heart values delivery system is associated with a reduction of all-cause mortality in severe aortic stenosis or insufficiency patients who are high risk or ineligible for aortic valve replacement.
Detailed description
Aortic valve diseases is usually caused by rheumatic fever, congenital aortic valve structural abnormality or degenerative aortic valve calcification. Transcatheter aortic valve implantation (TAVI) has evolved as an alternative to surgical aortic valve replacement (SAVR) with now more than 50,000 implantations in patients with symptomatic severe aortic stenosis, who were considered to be at very high or prohibitive operative risk.
This project take the incidence of all-cause mortality at 12 months since TAVI as the primary endpoint to evaluate the safety and efficacy, then take the procedure success rate, device success rate, incidence of severe adverse events, device operative performance, prosthetic valve performance and quality of life to evaluate transcatheter artificial aortic valve and transcatheter artificial heart values delivery system of Ningbo Jenscare Biotechnology Co., Ltd. in clinical application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jenscare TAVI | Experimental | Device: Jenscare TAVIPatients undergoing a Jenscare TAVI and delivery system |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Subjects ≥ 65 years of age;
- Severe aortic stenosis, as defined by ultrasonic cardiogram (peak velocity ≥4.0 m/s, or mean transaortic systolic pressure gradient ≥40 mmHg, or an aortic valve area of <1.0 cm2) or combined merger; severe aortic insufficiency (regurgitation ≥+++ or regurgitation area ≥0.3cm2) combined with left ventricular dilatation ( LVESD≥50mm or LVEDD≥65mm);or severe aortic valve insufficiency combined with left ventricular systolic dysfunction (LVEF<50%);
- Symptoms suggestive of aortic stenosis, NYHA class III or IV;
- Patients who are considered unsuitable for surgery are considered by two or more than two cardiovascular specialists (≥6% using Society of Thoracic Surgeons scoring system estimation; or there is a severe and irreversible organ damage to the patient, such as lung disease, liver disease, kidney disease and so on; or the patient's physical weakness can not be tolerated by surgery; or have other factors affecting surgery, such as postoperative chest radiosurgery, thoracic deformity, and diffuse severe calcification of the aorta, etc);
- A life expectancy of > 1 year;
Key exclusion criteria (18 listed)
- Untreated severe coronary stenosis and needs revascularization; or acute myocardial infarction occurred within 1 months, or coronary stent implantation in 1 month;
- Artificial heart valve and artificial valve ring have been implanted；
- Severe mitral insufficiency (regurgitation ≥+++) or mitral stenosis (valvular area<1.5 cm2)；
- left ventricular or atrial thrombus;
- Aortic annulus diameter <17mm or >27 mm;
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 |
|---|---|---|
| Jenscare TAVIJenscare TAVI and delivery system will implant a percutaneous bioprosthesis value, which is positioned in the native aortic valve, plays a role to control blood flow, and help your heart to work better. It may also shorten your recovery time to getting back to everyday activities. | Device | Jenscare TAVI |
Primary outcome
All-cause mortality
Time frame: 12 month
Cumulative incidence of a combination of all cause death at 12 month after TAVI
10 secondary outcomes
Procedure success rate
Time frame: During the TAVI procedure
Device success rate
Time frame: During the TAVI procedure
Incidence of severe adverse events
Time frame: During the TAVI procedure and 3 days,7 days, 30 days, 3 months, 6 months, 12 months after TAVI
Assessment of device operative performance
Time frame: During the TAVI procedure
Echocardiographic assessment of valve performance
Time frame: 30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance
Time frame: 30 days, 3 months, 6 months, 12 months after TAVI
Evaluation and improvement of quality of life
Time frame: Preoperative and 30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance
Time frame: 30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance
Time frame: 30 days, 3 months, 6 months, 12 months after TAVI
Echocardiographic assessment of valve performance
Time frame: 30 days, 3 months, 6 months, 12 months after TAVI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Derived from this study: PubMed 42087322Xiao B, Li M, Liu L, Shi J, Zhang H, Meng X, Chen L, Zhang X, Ma L, Dong N, Shang X, Yang J, Liu Y, Wang P, Xiao Y, Pan X, Wang J, Zhu D, Guo H, Liu J, Wang D, Xu Z, Song Z, Guo Y. Transapical Transcatheter Valve Implantation for Aortic Regurgitation: A Multicentre, Prospective Trial. Eur J Cardiothorac Surg. 2026 Aug 3;68(8):ezag065. doi: 10.1093/ejcts/ezag065.
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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.
Peng Cao, Doctor study director
Ningbo Jenscare Biotechnology Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A study testing Jenscare TAVI in people with Severe Aortic Stenosis and Aortic Regurgitation, run by Ningbo Jenscare Biotechnology Co., Ltd..
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 18 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: status not confirmed, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaolin Wang, Master (8617717875521 ext. 057463935666, Alice.w@linksmed.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 12 month). 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 NCT03788590, 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 8 Jan 2019.