Aortic StenosisNCT04815785
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
A study testing TaurusOne® transcatheter aortic valve replacement system in people with Aortic Stenosis, run by Peijia Medical Technology (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance criteria. 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?
- TaurusOne® transcatheter aortic valve replacement 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
- 22 Sep 2017to 30 May 2024
- 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 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 and are able to comply with the entire trial process;
- Age ≥ 70 years;
- Patients with severe calcific aortic stenosis confirmed by echocardiography (Transaortic flow velocity ≥ 4.0 m/s, or aortic-valve gradient ≥ 40 mmHg (1 mmHg = 0.133 kPa), or aortic valve area < 0.8 cm2, or effective orifice area < 0.5 cm2/m2);
- Patients who have symptoms obviously caused by aortic stenosis, NYHA Class II or worse;
- Patients who are unsuitable for conventional surgery evaluated by the cardiac team (including at least two cardiovascular surgeons) [13] *;
- Life expectancy after implantation of prosthetic valve is more than one year evaluated by the cardiac team (including at least two cardiac surgeons);
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- Aortic annulus diameter ≥ 18 mm and ≤ 29 mm (measured by cardiac CT);
- Ascending aorta diameter < 50 mm
- : If the patient meets any of the following criteria judged by a multidisciplinary cardiac team composed of cardiologists and cardiovascular surgeons, radiologists, anesthesiologists, etc. (at least two cardiovascular surgeons), the patient will be identified as unsuitable for conventional surgery (at least STS ≥ 8 points):
- Estimated risk of surgery-related death or disability > 50% within 1 year;
- ≥3 major organ damage that could not be improved by surgery;
- Obstacles related to surgical procedures judged as serious
Who cannot join
- Patients with bacteremia or toxemia;
- Previous endocarditis or active endocarditis;
- Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with elevated creatine kinase isoenzyme and troponin T) within 30 days;
- Any intracardiac mass, left ventricular or atrial thrombus, vegetation on echocardiography;
- Symptomatic atrial fibrillation that cannot be improved by drug therapy;
- Familial hypertrophic cardiomyopathy;
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- Mitral or tricuspid valve insufficiency (grade II regurgitation or higher);
- Previous aortic valve graft (mechanical or bioprosthetic valve);
- Known allergies to contrast agents, aspirin, heparin, ticlopidine drugs, nitinol shape memory alloy, or bovine products;
- Known contraindications or allergies to anticoagulant regimens, or inability to use anticoagulants throughout the trial;
- Other serious diseases that may reduce life expectancy to less than 12 months (such as clinically recurrent or metastatic cancer, congestive heart failure, etc.);
- Current substance abuse problems (e.g., alcohol, cocaine, heroin, etc.);
- Scheduled to undergo surgery that may result in protocol noncompliance or confounding in data interpretation.
- Cerebrovascular accident (CVA) in the past 6 months;
- Patients with common carotid artery or internal carotid artery or vertebral artery stenosis (>70%);
- White blood cell count <3×109/L, platelet count <50×109/L;
- Hemoglobin < 90 g/L;
- Patients with severe coagulopathy;
- Severe left ventricular dysfunction, left ventricular ejection fraction < 20%;
- Abdominal or thoracic aortic aneurysm;
- Hepatic encephalopathy or acute active hepatitis;
- On dialysis or baseline creatinine level > 2.5 mg/dL (221 μ mol/L);
- Bleeding tendency or history of coagulation disease or refusal of blood transfusion;
- Patients with active peptic ulcer or active gastrointestinal (GI) bleeding;
- Patients with neurological diseases that seriously affect mobility and activities of daily living;
- Patients with mental illness or psychological disorders who are unable to communicate effectively;
- Patients who need emergency surgery for any reason;
- Patients who have participated in other drug or medical device clinical trials within 3 months prior to screening;
- Other conditions that make the patient ineligible to participate in this clinical trial in judgement of investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Prospective, Single-Arm, Objective Performance Criteria Study to Evaluate the Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance criteria.
- Conditions
- Aortic Stenosis
- Being tested
- TaurusOne® transcatheter aortic valve replacement system
- 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.
TaurusOne® transcatheter aortic valve replacement systemDevice
The TaurusOne® Transcatheter Aortic Valve System consists of an aortic valve, an associated delivery catheter and a loading system. The aortic valve consists of a self-expanding nitinol frame, a sealing skirt and valve leaflets, which are made of bovine pericardium. The delivery system is mainly composed of conical head, opacity ring, inner tube, top ring, middle tube, outer tube, booster rod, stress diffusion catheter, handle, etc. The outflow end of the aortic valve is provided with three fixing holes evenly distributed on the circumference on the top ring of the delivery catheter, so as to facilitate the installation, delivery and release of the aortic valve. Before the operation, the aortic valve needs to be installed into the sheath of the delivery catheter as required.
| Study group | Role | What they receive |
|---|---|---|
| A single set of test | Experimental | The experimental apparatus consisted of artificial aortic valve, transporter and loading system Receives: Device: TaurusOne® transcatheter aortic valve replacement system |
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: 12 months
Secondary outcomes (3)
Device success rate (Immediate after procedure)
- Successful delivery and release of vascular access and prosthetic aortic valve, and successful withdrawal of the delivery catheter
- Accurate placement of prosthetic aortic valve at the anatomical site
- Prosthetic aortic valve meets the desired requirements (mean valve gradient < 20 mm Hg or maximal flow velocity < 3 m/s; No severe prosthetic valve regurgitation or perivalvular leak)
Measured: Immediate after procedure
Procedure success rate
A successful procedure is defined as successful implantation of the prosthetic aortic valve at the correct anatomical site 72 hours after the operation or before discharge without severe prosthetic valve regurgitation or perivalvular leak.
Measured: 72 hours after procedure/prior to discharge
Cardiac function improvement
NYHA functional classification
Measured: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start22 Sep 2017
- Primary completion11 May 2020
- Study completion30 May 2024 (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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fu Wai Hospital, Beijing, China, Second Affiliated Hospital, Zhejiang University, School of Medicine, West China Hospital, General Hospital of Shenyang Military Region, The Second Affiliated Hospital of Harbin Medical University, Second Xiangya Hospital of Central South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815785
- Sponsor's protocol ID
- CSP12000-2
- Status last verified
- Oct 2023
- First submitted
- 6 Mar 2021
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Single-Arm, Objective Performance Criteria Study to Evaluate the Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
- ClinicalTrials.gov ID
- NCT04815785
- Acronym / sponsor ID
- CSP12000-2
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fu Wai Hospital, Beijing, China, Second Affiliated Hospital, Zhejiang University, School of Medicine, West China Hospital, General Hospital of Shenyang Military Region, The Second Affiliated Hospital of Harbin Medical University, Second Xiangya Hospital of Central South University
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 25 Mar 2021 (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 TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis 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: TaurusOne® transcatheter aortic valve replacement systemThe experimental apparatus consisted of artificial aortic valve, transporter and loading system |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Patients who voluntarily participate and sign the informed consent and are able to comply with the entire trial process;
- Age ≥ 70 years;
- Patients with severe calcific aortic stenosis confirmed by echocardiography (Transaortic flow velocity ≥ 4.0 m/s, or aortic-valve gradient ≥ 40 mmHg (1 mmHg = 0.133 kPa), or aortic valve area < 0.8 cm2, or effective orifice area < 0.5 cm2/m2);
- Patients who have symptoms obviously caused by aortic stenosis, NYHA Class II or worse;
- Patients who are unsuitable for conventional surgery evaluated by the cardiac team (including at least two cardiovascular surgeons) [13] *;
Key exclusion criteria (29 listed)
- Patients with bacteremia or toxemia;
- Previous endocarditis or active endocarditis;
- Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with elevated creatine kinase isoenzyme and troponin T) within 30 days;
- Any intracardiac mass, left ventricular or atrial thrombus, vegetation on echocardiography;
- Symptomatic atrial fibrillation that cannot be improved by drug therapy;
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 |
|---|---|---|
| TaurusOne® transcatheter aortic valve replacement systemThe TaurusOne® Transcatheter Aortic Valve System consists of an aortic valve, an associated delivery catheter and a loading system. The aortic valve consists of a self-expanding nitinol frame, a sealing skirt and valve leaflets, which are made of bovine pericardium. The delivery system is mainly composed of conical head, opacity ring, inner tube, top ring, middle tube, outer tube, booster rod, stress diffusion catheter, handle, etc. The outflow end of the aortic valve is provided with three fixing holes evenly distributed on the circumference on the top ring of the delivery catheter, so as to facilitate the installation, delivery and release of the aortic valve. Before the operation, the aortic valve needs to be installed into the sheath of the delivery catheter as required. | Device | A single set of test |
Primary outcome
All-cause mortality at 12 months
Time frame: 12 months
All-cause mortality
3 secondary outcomes
Device success rate (Immediate after procedure)
Time frame: Immediate after procedure
Procedure success rate
Time frame: 72 hours after procedure/prior to discharge
Cardiac function improvement
Time frame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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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 TaurusOne® transcatheter aortic valve replacement system 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 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. 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?
Results are not available in the source record.
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: 12 months). 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 24 Oct 2023.