Aortic StenosisNCT04744857

Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System

A study testing The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system. in people with Aortic Stenosis, run by Peijia Medical Technology (Suzhou) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 70 years and older
Conditions the study is for: Aortic Stenosis
What is being tested?: The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 1 siteChina
Study dates: 13 Dec 2019to 16 Oct 2020
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 are willing to participate and sign the informed consent and can cooperate with the whole trial process;
Age ≥70 years old;
Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m /s, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area < 0.8cm2, or effective aortic valve orifice the product index is < 0.5cm2/m2);
Appear obvious symptoms caused by aortic stenosis, NYHA class Ⅱ or higher;
The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;
The life expectancy of the patient after implantation of the prosthetic valve was evaluated by the cardiac team (at least two specialists in cardiovascular surgery) as more than one year;
Patients with aortic ring diameter ≥18mm and ≤29mm (cardiac CT measurement);
The diameter of the ascending aorta of the patient was < 50mm.

Who cannot join

Patients with bacteremia or toxemia;
previous history or active endocarditis;
Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with increased creatine kinase isoenzyme and/or troponin T) within 30 days;
Echocardiography found any intracardiac mass, left ventricle or atrial thrombosis, vegetations;
Symptomatic atrial fibrillation that cannot be improved by medication;
Familial hypertrophic cardiomyopathy;

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Mitral valve and tricuspid valve insufficiency (reflux Ⅱ level above);
Prior aortic valve grafts (mechanical or biological valve stents);
Known allergy to contrast agent, aspirin, heparin, ticlopidine, nickel-titanium memory alloy, or bovine products;
Known to be contraindication or allergic to all anticoagulant regimens, or unable to use anticoagulant during the test;
Other serious diseases that may reduce life expectancy to less than 12 months (e.g. clinically recurrent or metastatic cancer, congestive heart failure, etc.)
Current drug abuse problem (e.g., alcohol, cocaine, heroin, etc.); Plan to undergo surgery that may cause nonadherence to protocol or confusion in data interpretation.
Cerebrovascular accident (CVA) in the past 6 months;
Patients with common or internal carotid or vertebral artery stenosis (> 70%);
WBC count < 3×109/L, platelet count < 50×109/ L;
Hemoglobin < 90g/L;
Patients with severe coagulation dysfunction;
Severe left ventricular dysfunction, left ventricular ejection fraction < 20%;
Abdominal or thoracic aortic aneurysm;
Hepatic encephalopathy or acute active hepatitis;
Receiving dialysis or a baseline creatinine level of > 3.0 mg/dL (266μmol/L);
Have bleeding tendency or history of coagulation disease or refuse blood transfusion;
Have active gastric ulcer or active gastrointestinal (GI) bleeding;
Suffer from neurological diseases that seriously affect the ability to move or live in daily life;
People with mental illness or mental disorder who cannot express themselves normally;
Need emergency surgery for any reason;
Screening participants who had participated in other drug or medical device clinical trials within the previous 3 months;
Other conditions considered by the investigator to be inappropriate for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Peiga Medical Technology (Suzhou) Co., Ltd
Suzhou, Jiangsu, 215025

Other trials in China

About this study

Official title: A Prospective，Multicenter, Single-arm Clinical Trial to Evaluate Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System

Read the detailed description

The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multicenter, single-arm clinical trial. According to the inclusion and exclusion criteria, sixty patients are planed been enrolled and implanted with TaurusOne® .Patients are seen at pre and post procedure, discharge, 30 days. The main follow-up included clinical symptoms and signs, cardiac ultrasound, CT, etc. The outcome included immediate device success, procedure success, And the major cardiovascular and cerebrovascular adverse events (MACCE, including mortality, stroke, myocardial infarction, reoperation, arrhythmia, conduction block).

Conditions: Aortic Stenosis
Being tested: The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading 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.

The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.Combination product
Also called The TaurusOne® transcatheter aortic valve replacement system features a retrievable delivery catheter system
Using the grip-loading system, the artificial aortic valve was squeezed and loaded into the sheath of the transporter through the vascular approach.The artificial aortic valve is delivered and positioned at the correct anatomical position for release. For example, the artificial main valve is displayed after partial release If the aortic valve is not in the correct anatomical position, the artificial aortic valve can be recovered and placed into the sheath tube of the transporter for re-positioning and release.

Study groups in NCT04744857
Study group	Role	What they receive
A single set of test	Experimental	The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system. Receives: Combination Product: The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite event rate at 30 days
Patient-oriented composite event including all-cause death，severe stroke，myocardial infarction, permanent pacemaker implantation，surgical reoperation and valve-in-valve.
Measured: 30 days after procedure

Secondary outcomes (4)

Device success rate (immediately after procedure)
Device success is defined as
- Vascular access, artificial aortic valve delivery and release were successful, and the delivery catheter was successfully withdrawn.
- The artificial aortic valve was implanted in an anatomically accurate position.
- The artificial aortic valve met the expected requirements (mean transvalvular pressure difference < 20mmHg or maximum flow rate < 3m/s; No serious manual initiative valve regurgitation or perivalvular leakage)
Measured: Immediately after procedure
Procedure success rate
Procedure success is defined as the artificial aortic valve successfully implanted in the correct anatomical position 72h after surgery or before discharge without severe artificial aortic valve regurgitation or perivalvular leakage.
Measured: 72 hours after procedure/prior to discharge
Cardiac function improvement
Cardiac function improvement is accessed by NYHA cardiac function classification increases from baseline to 30 days.
Measured: 30 days after procedure
Quality of life of patients
Quality of Life of patients accessed by EuroQol-5 Dimensions (EQ-5D) Questionnaire. The higher scores mean a worse health state. Recording changes from baseline to 30 days.
Measured: 30 days after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 201916 Oct 2020

First posted9 Feb 2021
Study start13 Dec 2019
Primary completion16 Oct 2020
Study completion16 Oct 2020

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
Model description: Preliminary data from the TaurusOne® clinical trial show good safety and efficacy in this trial without altering the artificial aorta To evaluate the safety and effectiveness of a transporter with a recoverable function. Take TaurusOne® in a clinical trial of compounding Endpoint event incidence was used as a target control.
Masking: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04744857
Sponsor's protocol ID: CSP12001
Status last verified: Feb 2021
First submitted: 29 Jan 2021
Last updated: 21 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective，Multicenter, Single-arm Clinical Trial to Evaluate Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System
ClinicalTrials.gov ID: NCT04744857
Acronym / sponsor ID: CSP12001
Conditions: Aortic Stenosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Peijia Medical Technology (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: General Hospital of Shenyang Military Region, Shanghai Zhongshan Hospital, Guangdong Provincial People's Hospital, The Second Affiliated Hospital of Harbin Medical University, Air Force Military Medical University, China, West China Hospital, Beijing Anzhen Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Central South University, Fu Wai Hospital, Beijing, China, China National Center for Cardiovascular Diseases, Shanghai Lingsi Medical Technology Co., Ltd.
Study start: 13 Dec 2019 (actual)
Primary completion: 16 Oct 2020 (actual)
Study completion: 16 Oct 2020 (actual)
First posted: 9 Feb 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Preliminary data from the TaurusOne® clinical trial show good safety and efficacy in this trial without altering the artificial aorta To evaluate the safety and effectiveness of a transporter with a recoverable function. Take TaurusOne® in a clinical trial of compounding Endpoint event incidence was used as a target control.

Arm	Type	Receives
A single set of test	Experimental	Combination Product: The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (8 listed)

Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;
Age ≥70 years old;
Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m /s, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area < 0.8cm2, or effective aortic valve orifice the product index is < 0.5cm2/m2);
Appear obvious symptoms caused by aortic stenosis, NYHA class Ⅱ or higher;
The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;

Key exclusion criteria (28 listed)

Patients with bacteremia or toxemia;
previous history or active endocarditis;
Acute myocardial infarction (Q-wave MI, or non-Q-wave MI with increased creatine kinase isoenzyme and/or troponin T) within 30 days;
Echocardiography found any intracardiac mass, left ventricle or atrial thrombosis, vegetations;
Symptomatic atrial fibrillation that cannot be improved by medication;

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
The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.Also: The TaurusOne® transcatheter aortic valve replacement system features a retrievable delivery catheter systemUsing the grip-loading system, the artificial aortic valve was squeezed and loaded into the sheath of the transporter through the vascular approach.The artificial aortic valve is delivered and positioned at the correct anatomical position for release. For example, the artificial main valve is displayed after partial release If the aortic valve is not in the correct anatomical position, the artificial aortic valve can be recovered and placed into the sheath tube of the transporter for re-positioning and release.	Combination product	A single set of test

Primary outcome

Composite event rate at 30 days
Time frame: 30 days after procedure
Patient-oriented composite event including all-cause death，severe stroke，myocardial infarction, permanent pacemaker implantation，surgical reoperation and valve-in-valve.

4 secondary outcomes

Device success rate (immediately after procedure)
Time frame: Immediately after procedure
Procedure success rate
Time frame: 72 hours after procedure/prior to discharge
Cardiac function improvement
Time frame: 30 days after procedure
Quality of life of patients
Time frame: 30 days after procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Individual participant dataSharing planned: No

Related trials for Aortic Stenosis

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

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?

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 8 inclusion and 28 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: finished, as of the sponsor's last update on 21 Feb 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Composite event rate at 30 days (time frame: 30 days after procedure). 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 NCT04744857.

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 21 Feb 2021.