Aortic StenosisNCT07908225
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
A study testing TAVR in people with Aortic Stenosis, run by Peijia Medical Technology (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and effectiveness of the TaurusNXT™ transcatheter aortic valve system in a patient population with symptomatic severe AS requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- TAVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2021to 29 Feb 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who voluntarily participate and sign the informed consent form, and are able to comply with the entire trial process.
- Age ≥ 70 years.
- Severe aortic stenosis (AS): Echocardiography shows a transaortic flow velocity ≥ 4.0 m/s, or a mean transaortic pressure gradient ≥ 40 mmHg (1 mmHg = 0.133 kPa), or an aortic valve area ≤ 1.0 cm², or an effective orifice area index ≤ 0.5 cm²/m²; for patients with low flow/low gradient, severe AS is confirmed by dobutamine stress echocardiography, Doppler ultrasound evaluation, or other imaging modalities.
- Symptomatic patients: symptoms such as dyspnea, chest pain, or syncope, with New York Heart Association (NYHA) functional class ≥ II (including class II), and these symptoms are clearly attributable to AS.
- Anatomically suitable for transcatheter aortic valve replacement (TAVR): including but not limited to valve calcification degree, aortic annulus diameter, aortic sinus diameter and height, coronary ostium height, and vascular access diameter.
- Expected life expectancy > 12 months after correction of AS.
- Assessed by the heart team (including at least two cardiovascular surgeons) as unsuitable for conventional surgical aortic valve replacement.
Who cannot join
- Subjects with bacteremia or septicemia.
- Active endocarditis.
- Any intracardiac mass, left ventricular or atrial thrombus, or vegetation detected on echocardiography.
- Severe mitral or tricuspid regurgitation.
- Known severe allergic reactions to contrast media, aspirin, heparin, ticlopidine-class drugs, nitinol, or bovine products.
- Other serious diseases that may reduce life expectancy to less than 12 months.
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- Current substance abuse issues (e.g., alcohol, cocaine, heroin, etc.).
- Subjects with severe coagulation disorders.
- Hemoglobin < 60 g/L.
- Currently undergoing dialysis or baseline creatinine level > 3.0 mg/dL (266 μmol/L).
- Severe left ventricular dysfunction with left ventricular ejection fraction < 20%.
- Stroke occurring within the past 3 months.
- Acute myocardial infarction (Q-wave MI or non-Q-wave MI with CK-MB > 2 times the upper limit of normal and/or elevated troponin) within the past 1 month.
- Abdominal or thoracic aortic aneurysm.
- Hepatic encephalopathy or acute active hepatitis.
- Neurological diseases severely affecting mobility and activities of daily living.
- Mental illness or psychological disorder preventing normal expression/communication.
- Participation in another drug or medical device clinical trial within 3 months prior to screening.
- Other conditions considered by the investigator as unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicenter, Single-Arm Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
To evaluate the safety and effectiveness of the TaurusNXT™ transcatheter aortic valve system in a patient population with symptomatic severe AS requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).
- Conditions
- Aortic Stenosis
- Being tested
- TAVR
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVRDevice
TAVR usingTaurusNXT® transcatheter aortic valve system
| Study group | Role | What they receive |
|---|---|---|
| TAVR Using TaurusNXT® transcatheter aortic valve system | Experimental | Not described Receives: Device: TAVR |
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: 1 year
Secondary outcomes (4)
Device Success
Vascular access, delivery and deployment of the prosthetic aortic valve were successful, and the delivery system was successfully withdrawn.
A prosthetic aortic valve was accurately implanted in the anatomical position. The prosthetic aortic valve met the expected requirements (mean transaortic pressure gradient < 20 mmHg or transaortic flow velocity < 3 m/s; no moderate or greater prosthetic aortic regurgitation or paravalvular leakage).
Measured: immediately after the procedure
Procedural Success
device success with no occurrence of death, disabling stroke, myocardial infarction, or conversion to surgery within 72 hours post-procedure or before discharge
Measured: Perioperative/Periprocedural
Improvement in cardiac function (NYHA functional class)
Measured: 1 year
Postoperative quality of life of subjects (EuroQol five-dimension questionnaire [EQ-5D] visual analogue scale [VAS] score)
The EuroQol five-dimension questionnaire (EQ-5D) visual analogue scale (VAS) score ranges from 0 to 100, with higher scores indicating a better self-rated health state.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start10 Sep 2021
- Primary completion29 Feb 2024
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 150 participants (actual)
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
- NCT07908225
- Sponsor's protocol ID
- CSP13000
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 2 Nov 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single-Arm Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
- ClinicalTrials.gov ID
- NCT07908225
- Acronym / sponsor ID
- CSP13000
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 2 Nov 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.
To evaluate the safety and effectiveness of the TaurusNXT™ transcatheter aortic valve system in a patient population with symptomatic severe AS requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVR Using TaurusNXT® transcatheter aortic valve system | Experimental | Device: TAVR |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Patients who voluntarily participate and sign the informed consent form, and are able to comply with the entire trial process.
- Age ≥ 70 years.
- Severe aortic stenosis (AS): Echocardiography shows a transaortic flow velocity ≥ 4.0 m/s, or a mean transaortic pressure gradient ≥ 40 mmHg (1 mmHg = 0.133 kPa), or an aortic valve area ≤ 1.0 cm², or an effective orifice area index ≤ 0.5 cm²/m²; for patients with low flow/low gradient, severe AS is confirmed by dobutamine stress echocardiography, Doppler ultrasound evaluation, or other imaging modalities.
- Symptomatic patients: symptoms such as dyspnea, chest pain, or syncope, with New York Heart Association (NYHA) functional class ≥ II (including class II), and these symptoms are clearly attributable to AS.
- Anatomically suitable for transcatheter aortic valve replacement (TAVR): including but not limited to valve calcification degree, aortic annulus diameter, aortic sinus diameter and height, coronary ostium height, and vascular access diameter.
Key exclusion criteria (19 listed)
- Subjects with bacteremia or septicemia.
- Active endocarditis.
- Any intracardiac mass, left ventricular or atrial thrombus, or vegetation detected on echocardiography.
- Severe mitral or tricuspid regurgitation.
- Known severe allergic reactions to contrast media, aspirin, heparin, ticlopidine-class drugs, nitinol, or bovine products.
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 |
|---|---|---|
| TAVRTAVR usingTaurusNXT® transcatheter aortic valve system | Device | TAVR Using TaurusNXT® transcatheter aortic valve system |
Primary outcome
All-cause mortality at 12 months
Time frame: 1 year
All-cause mortality
4 secondary outcomes
Device Success
Time frame: immediately after the procedure
Procedural Success
Time frame: Perioperative/Periprocedural
Improvement in cardiac function (NYHA functional class)
Time frame: 1 year
Postoperative quality of life of subjects (EuroQol five-dimension questionnaire [EQ-5D] visual analogue scale [VAS] score)
Time frame: 1 year
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 2 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Aortic Stenosis
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Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT Registry™): Registry Purpose and Research Objective
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR in people with Aortic Stenosis, 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 7 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at 12 months (time frame: 1 year). 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 2 Nov 2026.