Diseases of Aortic ValveNCT05580952
Clinical Trial in China
A study testing Transcatheter aortic valve replacement in people with Diseases of Aortic Valve and Aortic Regurgitation Disease, run by Genesis Medtech Corporation at 15 sites in China.
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 regurgitation disease who are at high or prohibitive surgical risk. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diseases of Aortic Valve, Aortic Regurgitation Disease
- 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
- 120 participants
- Where
- 15 sitesChina
- Study dates
- 14 Oct 2022to 1 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, 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;
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- 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, 15 recruiting
- Recruiting
Beijing Anzhen Hospital,Capital Medical University
Beijing
Yujie Zhou, Doctor, 010-64412431, jyjb@cueb.edu.cn
- Recruiting
Chinese PLA General Hoapital
Beijing
Yundai Chen, Doctor, 010-68182255, jfjzyygw@163.com
- Recruiting
Peking University Third Hospital
Beijing
Yida Tang, Doctor, 010-82266699, bysy@bjmu.edu.cn
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing
Chunlin Yin, Doctor, 010-83922345, xuanwuhospital@sina.com
- Recruiting
Xinqiao Hospital Army Medical Univer Sity
Chongqing
Yingbin Xiao, Doctor, 023-68755114, xinqiao@mail.xqhospital.com.cn
- Recruiting
Guangdong Academy of Medical Sciences
Guangdong
Huiming Guo, Doctor, 020-83827812, guohuiming@gdph.org.cn
- Recruiting
Nanjing Drum Tower Hospital
Nanjing
Dongjin Wang, Doctor, 025-83106666, glyyxfb@163.com
- Recruiting
Zhongshan Hospital
Shanghai
Chunsheng Wang, Doctor, 021-64041990, ec@zs-hospital.sh.cn
- Recruiting
WEST CHINA hospital
Sichuan
Yingqiang Guo, Doctor, 028-85422114, hxtfyyhfb@163.com
- Recruiting
The First Affiliated of Soochow University
Suzhou
Zhenya Shen, Doctor, 0512-65223637, sdfyyycgcc@163.com
- Recruiting
Xijing Hospital of the Fourth Military Medical University
Xi'an
Yang Liu, Doctor, 029-84775507, xjyyyb@fmmu.edu.cn
- Recruiting
Xiamen Cardiovascular Hospital Xiamen University
Xiamen
Yan Wang, Doctor, 0592-2292999, xmhchr@126.com
- Recruiting
Fuwai Yunnan Cardiovascular Hospital
Yunnan
Xiangbin Pan, Doctor, 0871-65199777, ynfwzhb@163.com
- Recruiting
The Second Affiliated Hospital of Zhejiang University
Zhejiang
Jianan Wang, Doctor, 0571-87783777, zrrs1@zju.edu.cn
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Deguang Feng, Doctor, 0371-66913114, Yuanban3031@163.com
About this study
Official title: Efficacy and Safety of the J-Valve Transcatheter Aortic Valve Replacement System in Patients With Aortic Regurgitation 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 regurgitation 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 group | Role | What they receive |
|---|---|---|
| Experimental: Treatment | Experimental | Device: J-Valve® valve delivery system Receives: Device: Transcatheter aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative all-cause mortality
All-cause mortality within 12 months of TAVR procedure
Measured: 12 months
Secondary outcomes (16)
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
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
Evaluation of bioprosthetic valve and cardiac function
Echocardiography was used to evaluate aortic valve function and cardiac function, including valve orifice area, transvalvular pressure difference, degree of valve regurgitation, left ventricular ejection fraction (LVEF), left ventricular diameter (LVEDD), moderate or more prosthetic valve regurgitation (central regurgitation \ perivalvular regurgitation), and degree of aortic stenosis.
Measured: 30 days, 6 months, 12 months
Functional Improvement of heart ( NYHA）
NYHA classification of cardiac function was evaluated after operation
Measured: 30 days, 6 months, 12 months
Quality of life（KCCQ）
Evaluation of postoperative Quality of life score improvement (KCCQ)
Measured: 30 days, 6 months, 12 months
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, 30 days, 6 months, 12 months
Myocardial infarction
Incidence of myocardial infarction
Measured: before discharge, 30 days, 6 months, 12 months
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, 30 days, 6 months, 12 months
Major bleeding (life-threatening or crippling)
Severe bleeding: BARC bleeding was defined as type 3a and above.
Measured: before discharge, 30 days, 6 months, 12 months
Acute kidney injury
The incidence of AKIN stage 2 and above events was recorded.
Measured: before discharge, 30 days, 6 months, 12 months
Conduction block and malignant arrhythmia
The incidence of conduction block and malignant arrhythmias
Measured: before discharge, 30 days, 6 months, 12 months
Permanent pacemaker implantation
Permanent pacemaker implantation rate
Measured: before discharge, 30 days, 6 months, 12 months
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, 30 days, 6 months, 12 months
Device defects
Incidence of device defects
Measured: intraoperative
The incidence of adverse events
Incidence of adverse events
Measured: 12 months
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.
- First posted14 Oct 2022
- Study start14 Oct 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diseases of Aortic ValveStudies 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
- Genesis Medtech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580952
- Sponsor's protocol ID
- S202112
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- 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 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the J-Valve Transcatheter Aortic Valve Replacement System in Patients With Aortic Regurgitation Disease
- ClinicalTrials.gov ID
- NCT05580952
- Acronym / sponsor ID
- S202112
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Genesis Medtech CorporationIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 14 Oct 2022 (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.
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 regurgitation disease who are at high or prohibitive surgical risk.
Detailed description
This study is a prospective, multicenter, single-arm, clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Treatment | Experimental | Device: Transcatheter aortic valve replacementDevice: J-Valve® valve delivery system |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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;
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 |
|---|---|---|
| Transcatheter aortic valve replacementTranscatheter aortic valve replacement system | Device | Experimental: Treatment |
Primary outcome
Cumulative all-cause mortality
Time frame: 12 months
All-cause mortality within 12 months of TAVR procedure
16 secondary outcomes
Device success
Time frame: 30 days
Procedural success
Time frame: immediate post-surgical
Evaluation of bioprosthetic valve and cardiac function
Time frame: 30 days, 6 months, 12 months
Functional Improvement of heart ( NYHA）
Time frame: 30 days, 6 months, 12 months
Quality of life（KCCQ）
Time frame: 30 days, 6 months, 12 months
Major cardiovascular and cerebrovascular adverse events (MACCE)
Time frame: before discharge, 30 days, 6 months, 12 months
Myocardial infarction
Time frame: before discharge, 30 days, 6 months, 12 months
Stroke
Time frame: before discharge, 30 days, 6 months, 12 months
Major bleeding (life-threatening or crippling)
Time frame: before discharge, 30 days, 6 months, 12 months
Acute kidney injury
Time frame: before discharge, 30 days, 6 months, 12 months
Conduction block and malignant arrhythmia
Time frame: before discharge, 30 days, 6 months, 12 months
Permanent pacemaker implantation
Time frame: before discharge, 30 days, 6 months, 12 months
TAVI related complications
Time frame: before discharge, 30 days, 6 months, 12 months
Device defects
Time frame: intraoperative
The incidence of adverse events
Time frame: 12 months
The incidence of serious adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- 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. This study is not recruiting at the moment.
15 sites in 1 country: see every site and its status.
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 Regurgitation 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 22 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 14 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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?
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 14 Oct 2022.