Aortic Stenosis Treated With TAVINCT07392359
Zhicheng TAVR Robot
A study testing TAVR Assistance System and TAVR by manual in people with Aortic Stenosis Treated With TAVI, run by Zhicheng Medical Technology (Jiaxing) Co, Ltd.
Trial summary
Use of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit in Patients With Severe Aortic Stenosis to Evaluate the Safety and Efficacy of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit for Use as an Adjunct to Transcatheter Aortic Valve… Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Stenosis Treated With TAVI
- What is being tested?
- TAVR Assistance System and TAVR by manual
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 15 Oct 2026
- 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥65 years old, gender is not limited;
- Patients assessed by a cardiac multidisciplinary team (MDT) expert panel as having severe aortic stenosis and suitable for transcatheter aortic valve replacement;
- Severe aortic stenosis was defined as echocardiographically demonstrated transaortic valve flow velocity ≥4.0 m/s, or transaortic valve pressure differential ≥40 mmHg (1 mmHg=0.133 kPa), or aortic orifice area <1.0 cm2, or effective aortic orifice area index <0.6 cm2/m2; for low-pressure-differential-low-flow rate by dopa-phenobutylamine loading test, Doppler ultrasound evaluation or other imaging means of assessment for those judged to have severe aortic stenosis.
- Have a core laboratory assessment that the patient is anatomically suitable for transcatheter aortic valve replacement;
- Patients who understand the purpose of the trial, voluntarily participate in the trial, sign an informed consent form, and are willing to cooperate in the follow-up.
Who cannot join
- Patients whose access or aortic root anatomical pattern is unsuitable for TAVR treatment;
- Poor peripheral arterial conditions that preclude transfemoral TAVR;
- Aortic annulus horizontal pinch angle ≥65° as measured by preoperative MDCT;
- Patients at high risk of coronary obstruction requiring intraoperative coronary protection measures;
- Patients requiring intraoperative delivery with a grapple assist system;
- Previous implantation of a prosthetic aortic valve (bioprosthetic or mechanical);
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- Active stage of infective endocarditis or other active infection;
- Combined mitral, tricuspid or severe macrovascular lesions requiring surgical or interventional intervention;
- Echocardiography suggestive of left ventricular thrombus, intracardiac mass or redundant organisms;
- Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathy (e.g. amyloidosis, haemochromatosis, nodular disease, etc.), constrictive pericarditis;
- Severe obstruction of the left ventricular outflow tract without corrective measures;
- Severe pulmonary hypertension (pulmonary artery systolic pressure >70 mmHg measured by ultrasound);
- Severe right heart dysfunction as suggested by a combined clinical and ultrasound assessment;
- Severe left heart systolic insufficiency (left ventricular ejection fraction <30%);
- Cardiogenic shock or haemodynamic instability requiring ventricular assist device therapy within 30 days prior to enrolment;
- End-stage heart failure (ACC/AHA Stage D), or post cardiac transplantation, or awaiting cardiac transplantation;
- Acute myocardial infarction within 30 days prior to enrolment;
- Has had a stroke within 3 months prior to enrolment;
- Stenosis of the common or internal carotid artery or vertebral artery (>70% stenosis) requiring treatment as recommended by the relevant disciplinary consultation;
- Severe cardiac and aortic disease requiring concomitant treatment, including ascending aortic aneurysm (maximum diameter ≥ 50 mm);
- Severe renal insufficiency (estimated glomerular filtration rate <30mL/min/1.73m2);
- Active peptic ulcer or history of upper gastrointestinal bleeding within 3 months prior to enrolment;
- Severe coagulopathy; Patients with known intolerance to anticoagulant, antiplatelet drugs or anaesthetic drugs; Patients who have participated in other drug or medical device clinical trials prior to enrolment that have not met the primary endpoint; Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective, Multicentre, Randomised Controlled, Non-Inferiority Clinical Trial Evaluating the Safety and Efficacy of the TAVR Assist System and Its Disposable Kit for Use as an Adjunct to TAVR
Use of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit in Patients With Severe Aortic Stenosis to Evaluate the Safety and Efficacy of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit for Use as an Adjunct to Transcatheter Aortic Valve Replacement
- Conditions
- Aortic Stenosis Treated With TAVI
- Being tested
- TAVR Assistance System, TAVR by manual
- Keywords
- TAVR Assist System, Aortic stenosis treated with TAVI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR Assistance SystemDevice
Whether or not TAVR procedures are performed with a TAVR assist system
TAVR by manualOther
TAVR by manual
| Study group | Role | What they receive |
|---|---|---|
| TAVR with TAVR Assistance System | Experimental | Not described Receives: Device: TAVR Assistance System |
| TAVR By Manual | Placebo comparator | Not described Receives: Other: TAVR by manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success at exit from OR, hybrid room or cath lab post-index procedure
Absence of procedural mortality; and Successful access, delivery, and retrieval of transcatheter delivery system; and Deployment and correct positioning of a single intended THV; and Freedom from re-intervention related to the device or access procedure
Measured: Immediate after procedure
Secondary outcomes (7)
Device Success
Absence of procedure mortality; and Correct position of a single prosthetic heart valve Intended performance of the prosthetic heart valve (i.e., no prosthesis mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s; and no moderate or severe prosthetic valve regurgitation) Intended performance of the prosthetic heart valve (i.e., no prosthesis mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s; and no moderate or severe prosthetic valve regurgitation)
Measured: 30 days
Cardiac function changement
Cardiac function changement is accessed by NYHA cardiac function classification increases from baseline to 30 days
Measured: Baseline，30 days
Prosthetic aortic valve function
Effective orifice area, mean transvalvular pressure difference, degree of regurgitation (mid-valve, peri-valve), degree of stenosis, etc.
Measured: 1、immediately after the procedure; 2、3 days; 3、30 days
Duration of aortic valve replacement
Time from start of delivery of prosthetic aortic valve by valve delivery system to successful implantation of prosthetic aortic valve
Measured: During the procedure
Total exposure of the operator to radiation
The doctor wears radiation detection equipment and records the total radiation exposure during the surgical procedure
Measured: During the procedure
Number of surgical staff
Measured: During the procedure
Evaluation of Device Performance with questionnaires
For test group only，using questionnaires to evaluate Device performance
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis Treated With TAVIStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhicheng Medical Technology (Jiaxing) Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xiamen Cardiovascular Hospital, Xiamen University, Fu Wai Hospital, Beijing, China, Beijing Anzhen Hospital, The General Hospital of Northern Theater Command, Second Xiangya Hospital of Central South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392359
- Sponsor's protocol ID
- 1RAD0008
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre, Randomised Controlled, Non-Inferiority Clinical Trial Evaluating the Safety and Efficacy of the TAVR Assist System and Its Disposable Kit for Use as an Adjunct to TAVR
- ClinicalTrials.gov ID
- NCT07392359
- Acronym / sponsor ID
- 1RAD0008
- Conditions
- Aortic Stenosis Treated With TAVI
- Keywords
- TAVR Assist System, Aortic stenosis treated with TAVI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Zhicheng Medical Technology (Jiaxing) Co, LtdIndustry (pharma, biotech, devices)
- Collaborators
- Xiamen Cardiovascular Hospital, Xiamen University, Fu Wai Hospital, Beijing, China, Beijing Anzhen Hospital, The General Hospital of Northern Theater Command, Second Xiangya Hospital of Central South University
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 6 Feb 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.
Use of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit in Patients With Severe Aortic Stenosis to Evaluate the Safety and Efficacy of the Transcatheter Aortic Valve Replacement Surgical Assist System and its Disposable Kit for Use as an Adjunct to Transcatheter Aortic Valve Replacement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVR with TAVR Assistance System | Experimental | Device: TAVR Assistance System |
| TAVR By Manual | Placebo comparator | Other: TAVR by manual |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age ≥65 years old, gender is not limited;
- Patients assessed by a cardiac multidisciplinary team (MDT) expert panel as having severe aortic stenosis and suitable for transcatheter aortic valve replacement;
- Severe aortic stenosis was defined as echocardiographically demonstrated transaortic valve flow velocity ≥4.0 m/s, or transaortic valve pressure differential ≥40 mmHg (1 mmHg=0.133 kPa), or aortic orifice area <1.0 cm2, or effective aortic orifice area index <0.6 cm2/m2; for low-pressure-differential-low-flow rate by dopa-phenobutylamine loading test, Doppler ultrasound evaluation or other imaging means of assessment for those judged to have severe aortic stenosis.
- Have a core laboratory assessment that the patient is anatomically suitable for transcatheter aortic valve replacement;
- Patients who understand the purpose of the trial, voluntarily participate in the trial, sign an informed consent form, and are willing to cooperate in the follow-up.
Key exclusion criteria (23 listed)
- Patients whose access or aortic root anatomical pattern is unsuitable for TAVR treatment;
- Poor peripheral arterial conditions that preclude transfemoral TAVR;
- Aortic annulus horizontal pinch angle ≥65° as measured by preoperative MDCT;
- Patients at high risk of coronary obstruction requiring intraoperative coronary protection measures;
- Patients requiring intraoperative delivery with a grapple assist system;
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 |
|---|---|---|
| TAVR Assistance SystemWhether or not TAVR procedures are performed with a TAVR assist system | Device | TAVR with TAVR Assistance System |
| TAVR by manualTAVR by manual | Other | TAVR By Manual |
Primary outcome
Technical Success at exit from OR, hybrid room or cath lab post-index procedure
Time frame: Immediate after procedure
Absence of procedural mortality; and Successful access, delivery, and retrieval of transcatheter delivery system; and Deployment and correct positioning of a single intended THV; and Freedom from re-intervention related to the device or access procedure
7 secondary outcomes
Device Success
Time frame: 30 days
Cardiac function changement
Time frame: Baseline，30 days
Prosthetic aortic valve function
Time frame: 1、immediately after the procedure; 2、3 days; 3、30 days
Duration of aortic valve replacement
Time frame: During the procedure
Total exposure of the operator to radiation
Time frame: During the procedure
Number of surgical staff
Time frame: During the procedure
Evaluation of Device Performance with questionnaires
Time frame: immediately after the procedure
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 6 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR Assistance System and TAVR by manual in people with Aortic Stenosis Treated With TAVI, run by Zhicheng Medical Technology (Jiaxing) 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 5 inclusion and 23 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: opening soon, as of the sponsor's last update on 6 Feb 2026. 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. Some participants in this study may receive a placebo. 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 Zang Rongyue (+8613161963311, zangrongyue@peijiamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success at exit from OR, hybrid room or cath lab post-index procedure (time frame: Immediate after procedure). 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 6 Feb 2026.