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Diseases of Aortic ValveNCT05607667

Clinical Trial in China for Aortic Valve Stenosis

A study testing Transcatheter aortic valve replacement in people with Diseases of Aortic Valve and Aortic Stenosis Disease, run by Genesis Medtech Corporation at 15 sites 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

The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Transcatheter aortic valve replacement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
15 sitesChina
Study dates
14 Oct 2022to 3 Jul 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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age ≥ 65;
  • Patients with symptomatic aortic valve regurgitation diseases, and New York Heart Association (NYHA) ≥ II;
  • Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have been evaluated as inoperable by the surgical team [defined as rate of death #50% within 30 d post-surgery or accompanied with irreversible occasions of other factors prevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (Note: age of inoperable patients can be expanded to ≥ 50);
  • Aortic valve anatomy is suitable for TAVR evaluated by the investigators;
  • Patients who can sign informed consent form, and are willing to accept relevant examinations and clinical follow-ups.

Who cannot join

  • Active endocarditis;
  • Acute myocardial infarction or coronary revascularization occurred within 1 month before procedure;
  • Cerebrovascular accident (CVA) occurred within 30 days before procedure;
  • The echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle and left atrium;
  • Hypertrophic obstructive cardiomyopathy;
  • Other valve diseases that need interventions;
Show all 21Show fewer
  • Previous aortic valve implantation (mechanical or biological);
  • Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products;
  • Known allergy or contraindication to all anticoagulation, or anticoagulation can not be used during the TAVR;
  • In presence one of the following (from selection to the day of procedure index): a other diseases that may shorten life expectancy to less than 12 months (recurrent or metastatic cancer, congestive heart failure); b drug abuse (such as cocaine, heroin and so on); c planned additional operations that may result in incompliance or data confusion;
  • Stenosis of common carotid artery, internal carotid artery or vertebral artery #70%;
  • Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
  • Hepatic encephalopathy or acute active hepatitis;
  • Receiving hemodialysis;
  • Bleeding tendency or history of coagulopathy or refuse to receive transfusion;
  • Active gastrointestinal (GI) ulcer or bleeding;
  • Severe dementia;
  • Patients who need emergency surgery for any reason;
  • Patients are participating in other drugs or medical devices clinical trial;
  • Pregnant or plan to be pregnant, or are taking estrogen or estrogen-like drugs (Women suspected of pregnancy must have a negative serum or urine test for human villous gonadotropin prior to enrollment in the study);
  • Other inappropriate occasions according to the investigators.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Beijing Anzhen Hospital,Capital Medical University

    Beijing

  • Chinese PLA General Hoapital

    Beijing

  • Peking University Third Hospital

    Beijing

  • Xuanwu Hospital Capital Medical University

    Beijing

  • Xinqiao Hospital Army Medical Univer Sity

    Chongqing

  • Guangdong Academy of Medical Sciences

    Guangdong

  • Nanjing Drum Tower Hospital

    Nanjing

  • Zhongshan Hospital

    Shanghai

  • WEST CHINA hospital

    Sichuan

  • The First Affiliated of Soochow University

    Suzhou

  • Xijing Hospital of the Fourth Military Medical University

    Xi'an

  • Xiamen Cardiovascular Hospital Xiamen University

    Xiamen

  • Fuwai Yunnan Cardiovascular Hospital

    Yunnan

  • The Second Affiliated Hospital of Zhejiang University

    Zhangjiang

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: Efficacy and Safety of the J-Valve Transcatheter Aortic Valve Replacement System in Patients With Aortic Stenosis Disease

The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk.

Read the detailed description

This study is a prospective, multicenter, single-arm, clinical study.

Being tested
Transcatheter aortic valve replacement
Medical subject headings
Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcatheter aortic valve replacementDevice

    Transcatheter aortic valve replacement system

Study groups in NCT05607667
Study groupRoleWhat they receive
Experimental: TreatmentExperimentalDevice: J-Valve® valve delivery system， Transvascularized biological aortic valve system
Receives: Device: Transcatheter aortic valve replacement

What is being measured

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

  1. Cumulative all-cause mortality

    All-cause mortality within 12 months of TAVR procedure

    Measured: 12 months

Secondary outcomes (16)

  1. Device success

    No operative death;The instrument was placed in the correct anatomical position, and the delivery assembly was successfully entered and withdrawn;No device-related surgical or interventional intervention (other than permanent pacemaker implantation)

    Measured: 30 days

  2. Procedural success

    Technical success,No death,No device-related surgical or interventional intervention (except permanent pacemaker implantation),The artificial aortic valve achieved the expected value (mean transaortic pressure difference < 20mmHg or transaortic flow velocity < 3m/s; No moderate or greater artificial aortic regurgitation or perivalvular leakage)

    Measured: : immediate post-surgical

  3. Evaluation of bioprosthetic valve and cardiac function Evaluation of bioprosthetic valve and cardiac function Evaluation of bioprosthetic valve and cardiac function

    Echocardiography was used to evaluate aortic valve function and cardiac function

    Measured: 30 days, 6 months, 12 months

  4. Functional Improvement of heart ( NYHA）

    NYHA classification of cardiac function was evaluated after operation

    Measured: 30 days, 6 months, 12 months

  5. Quality of life（KCCQ）

    Evaluation of postoperative Quality of life score improvement (KCCQ)

    Measured: 30 days, 6 months, 12 months

  6. Major cardiovascular and cerebrovascular adverse events (MACCE)

    Major adverse cardiovascular and cerebrovascular events (MACCE) included mortality, stroke, myocardial infarction, reoperation, arrhythmia, and conduction block.

    Measured: before discharge/7days, 30 days, 6 months, 12 months

  7. Myocardial infarction

    Incidence of myocardial infarction

    Measured: before discharge/7days, 30 days, 6 months, 12 months

  8. Stroke

    Grades include ischemic stroke (including transient ischemic attack, TIA) and hemorrhagic stroke Grades included ischemic stroke (including transient ischemic attack, TIA) and hemorrhagic stroke; Definitions included disabling stroke (modified Rankin score ≥2 at 90 days after stroke with an increase of >1 point) and nondisabling stroke (modified Rankin score <2 at 90 days after stroke with no increase in score). Stroke events should be recorded and the causes analyzed in detail.

    Measured: before discharge/7days, 30 days, 6 months, 12 months

  9. Major bleeding (life-threatening or crippling)

    Severe bleeding: BARC bleeding was defined as type 3a and above

    Measured: before discharge/7days, 30 days, 6 months, 12 months

  10. Acute kidney injury

    The incidence of AKIN stage 2 and above events was recorded.

    Measured: before discharge/7days, 30 days, 6 months, 12 months

  11. Conduction block and malignant arrhythmia

    The incidence of conduction block and malignant arrhythmias

    Measured: before discharge/7days, 30 days, 6 months, 12 months

  12. Permanent pacemaker implantation

    Permanent pacemaker implantation rate

    Measured: before discharge/7days, 30 days, 6 months, 12 months

  13. TAVI related complications

    These include conversion to surgery, accidental mechanical cardiopulmonary assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, cardiac tamponade, endocarditis, valve thrombosis, valve ectopic (displacement, embolization, misrelease), aortic dissection, aortic root rupture, and peripheral vascular complications.

    Measured: before discharge/7days, 30 days, 6 months, 12 months

  14. Device defects

    Incidence of device defects

    Measured: intraoperative

  15. The incidence of adverse events The incidence of adverse events

    Incidence of adverse events

    Measured: 12 months

  16. The incidence of serious adverse events

    Incidence of serious adverse events

    Measured: 12 months

Timeline

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

  1. First posted7 Nov 2022
  2. Study start14 Oct 2022
  3. Primary completion3 Jul 2024
  4. Study completion3 Jul 2024

Resources

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05607667
Sponsor's protocol ID
S202112-01
Status last verified
Jul 2025
First submitted
27 Oct 2022
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter aortic valve replacement in people with Diseases of Aortic Valve and Aortic Stenosis Disease, run by Genesis Medtech Corporation at 15 sites 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 5 inclusion and 21 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 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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?

Cumulative all-cause mortality (time frame: 12 months). 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 NCT05607667.

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 28 Jul 2025.

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