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Active, not recruitingNCT07908225Updated Nov 2, 2026

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

An interventional study of TAVR in Aortic Stenosis, sponsored by Peijia Medical Technology (Suzhou) Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Peijia Medical Technology (Suzhou) Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years after the study started (first participant enrolled Sep 2021, registered Sep 2026).
Updated Nov 2, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
70 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 67 studies in Aortic Valve Stenosis with a site in China — 41 open to participants now, 49 under way, 3 of them phase 3. Aortic Valve Stenosis · China.

Enrollment
17th of 47
150 · median 120
Started
2021
with 6 others
No phase
37 of 67
20 open now
Primary completion
2024-02
later than 9 of 48 live
Registered
67th of 67
by date
Lead sponsor
4 of 67
Peijia Medical Technology (Suzhou) Co., Ltd.

Among the 67 studies in Aortic Valve Stenosis with a site in China, this one is the 17th largest by enrollment of the 47 interventional ones, is one of 7 that started in 2021, is one of 37 with no phase, reaches primary completion later than 9 of the 48 other live ones, and was the 67th registered.

By phase

67 studies; the count open now beside each. This study's row is marked.

No phasethis study37 · 20 open
Observational20 · 14 open
Phase 35 · 3 open
Phase 44 · 3 open
Phase 21 · 1 open

By the year they started

First in 2012; this study’s year is marked. 7 started in 2021.

Size and results

Median enrollment 120 across the 47 interventional studies, 465 across the 20 observational. Of the 7 that completed or were terminated, 2 (29%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 67 studies in Aortic Valve Stenosis with a site in China, or all of them as a file.
02

Study 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).

03

Conditions studied

  • Aortic Stenosis
04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who voluntarily participate and sign the 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 (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 > 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.

Exclusion criteria

Exclusion Criteria:

  • 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 to less than 12 months.
  • Current substance abuse issues (e.g., alcohol, cocaine, heroin, etc.).
  • Subjects with severe coagulation disorders.
  • \< 60 g/L.
  • Currently undergoing dialysis or baseline creatinine level > 3.0 mg/dL (266 μmol/L).
  • Severe left ventricular dysfunction with \< 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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    TAVR Using TaurusNXT® transcatheter aortic valve system

    Device: TAVR

Interventions

  • DeviceTAVR

    TAVR usingTaurusNXT® transcatheter aortic valve system

06

What researchers measure

Primary outcomes

  1. All-cause mortality at 12 months

    All-cause mortality

    Time frame: 1 year

Secondary outcomes

  1. 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).

    Time frame: immediately after the procedure

  2. 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

    Time frame: Perioperative/Periprocedural

  3. Improvement in cardiac function (NYHA functional class)

    Time frame: 1 year

  4. 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.

    Time frame: 1 year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2021 to primary completion in Feb 2024, 29 months.

Of 111 industry-sponsored interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 54. This study's 29 months is close to that.

Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2026
First posted
Nov 2, 2026
StartActual
Sep 10, 2021
Primary completionActual
Feb 29, 2024
CompletionEst.
Feb 29, 2028
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07908225
Lead sponsor
Peijia Medical Technology (Suzhou) Co., Ltd.
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Sep 10, 2021
Primary completion
Feb 29, 2024
Completion
Feb 29, 2028 (estimated)
Last update
Nov 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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