Aortic Valve DiseaseNCT03025971
Safety & Efficacy of the J-Valve Ausper System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation
A study testing J-Valve Transcatheter Aortic valve replacement in people with Aortic Valve Disease, run by JC Medical, Inc., an affiliate of Edwards Lifesciences LLC at 3 sites in China.
Trial summary
A prospective, multicenter, nonrandomized, single-arm, clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- J-Valve Transcatheter Aortic valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 3 sitesChina
- Study dates
- Mar 2014to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Age ≥18years of age
- Presents with symptomatic aortic stenosis and/or aortic regurgitation, as well as NYHA rating of NYHA ≥ II
- Has undergone the diagnosis of at least one interventional cardiologist and two cardiac surgeons: the patients are contraindicated for traditional open heart valve replacement surgery (defined as 30 days post-op mortality risk >50%, irreversible complications, or other influential post-operative factors [such as severe calcification in the ascending aorta and aortic valve, weak physical condition, chest deformities, severe liver diseases, severe lung diseases, etc.] or high risk for surgery (LogEuroSCORE≥20% and or STS≥8)
- Has a diagnosis from at least one interventional cardiologist and two cardiac surgeons that the patient may benefit from a valve implantation
- Severe aortic stenosis with electrocardiography results as follows: mean transvalvular pressure gradient ≥40 mmHg or maximal forward aortic blood flow velocity of ≥4.0 m/s, aortic valve area < 0.8 cm2 (or AVA index < 0.5 cm2/m2); and/or severe aortic regurgitation, electrocardiography results show symptomatic moderate regurgitation or severe regurgitation
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- Without severe pulmonary arterial hypertension
- The patient is willing to cooperate with all follow-up visits.
- Anatomical Inclusion Criteria:
- Aortic annulus >19mm and <29mm, standardized using cardiac CT measurements;
- Ascending aortic diameter <50mm at the sinotubular junction.
Who cannot join
- Patients with infection or who have any sign of infection
- Previous history of endocarditis or patients with active endocarditis
- Incidence of acute myocardial infarction within the past 30 days (Q-wave MI, or non Q-wave MI with creatine kinase, an increase in troponin T)
- Any cardiac mass discovered during echocardiography, left ventricular or atrial thrombosis
- Suffering from uncontrollable atrial fibrillation
- Hereditary hypertrophic cardiomyopathy
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- Mitral or tricuspid valve insufficiency (Class Ⅱ regurgitation or greater)
- Has previously undergone aortic valve implantation (mechanical valve or biological valve frame)
- Is known to be allergic to contrast agents, aspirin, heparin, ticlopidine medications, nitinol or porcine products
- Is known to be contraindicated for or is allergic to all anti-coagulants or is unable to use anti-coagulants during the study
- Is known to have one of the following conditions (according to evaluations beginning from screening through the day of the procedure):
- Other diseases that may reduce the life expectancy to less than 12 months (such as clinically recurrent or metastatic cancer, congestive heart failure, etc.)
- Currently has drug abuse problems (such as alcohol, cocaine, heroin, etc.)
- Plans to undergo surgery that may result in non-compliance with the study protocol or that may cause confusion in data interpretation.
- Has experienced a cerebrovascular accident (CVA) within the last 6 months
- Patients suffering from stenosis of the carotid, internal carotid, or vertebral arteries (70%)
- White cell count <3×109/L, platelet count<50×109/L
- Hemoglobin <90 g/L
- Severely lowered left ventricular function, left ventricular ejection fraction < 20 %
- Aortic aneurysm in the abdomen or chest
- Hepatic encephalopathy or acute active hepatitis
- Currently undergoing dialysis or baseline creatine levels >2.5 mg/dL (221μmoI/L)
- Prone to bleeding, has a history of clotting disorders or refuses blood transfusions
- Active ulcer or active gastrointestinal (GI) bleeding
- Suffering from nervous system diseases that severely influence the patients' ability to move or to perform daily activities
- Patients with severe dementia
- Any reason for emergent surgery
- Taking part in other clinical trials for pharmaceuticals or medical devices
- Those who are pregnant, plan to become pregnant, or who are taking estrogen or estrogen-like drugs (women suspected of being pregnant must test negative on a urine pregnancy test or for chorionic gonadotropin serum).
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Trial locations and contacts
3 sites in 1 country.
China3 sites
West China Hospital
Chengdu
Zhongshan Hospital
Shanghai
Fuwai Cardiovascular Hospital
Yunnan
About this study
Official title: Efficacy and Safety Evaluation for The Interventional Aortic Valve Bioprosthesis and Delivery System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation With Elevated Surgical Risk
A prospective, multicenter, nonrandomized, single-arm, clinical study.
Read the detailed description
To evaluate the safety and efficacy of the J-Valve Ausper system for the treatment of patients with severe aortic stenosis and/or aortic regurgitation with elevated risk for surgery.
- Conditions
- Aortic Valve Disease
- Being tested
- J-Valve Transcatheter Aortic valve replacement
- Keywords
- Severe Aortic Stenosis and/or severe aortic regurgitation
- 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.
J-Valve Transcatheter Aortic valve replacementDevice
Also called TAVI
Transapical Transcatheter Aortic Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Single arm observational study | Other | Intervention: J-Valve Transcatheter Aortic valve replacement. Prospective, multi-center, single arm observational study. Subjects will include patients with severe aortic valve stenosis and/or severe aortic regurgitation who require replacement of their native aortic valve. Receives: Device: J-Valve Transcatheter Aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality
Measured: 12 months
Secondary outcomes (1)
Cardiac function improvement
New York Heart Association (NYHA) Functional class
Measured: 30 days, 6 months, 12 months and annually up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startMar 2014
- Primary completionApr 2016
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ji Zhang, MD, Study director, CEO, President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025971
- Sponsor's protocol ID
- S20131216
- Status last verified
- Sep 2024
- First submitted
- 12 Jan 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation for The Interventional Aortic Valve Bioprosthesis and Delivery System in Patients With Severe Aortic Stenosis and/or Aortic Regurgitation With Elevated Surgical Risk
- ClinicalTrials.gov ID
- NCT03025971
- Acronym / sponsor ID
- S20131216
- Conditions
- Aortic Valve Disease
- Keywords
- Severe Aortic Stenosis and/or severe aortic regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 20 Jan 2017 (estimated)
- 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.
A prospective, multicenter, nonrandomized, single-arm, clinical study.
Detailed description
To evaluate the safety and efficacy of the J-Valve Ausper system for the treatment of patients with severe aortic stenosis and/or aortic regurgitation with elevated risk for surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm observational study | Other | Device: J-Valve Transcatheter Aortic valve replacementIntervention: J-Valve Transcatheter Aortic valve replacement. Prospective, multi-center, single arm observational study. Subjects will include patients with severe aortic valve stenosis and/or severe aortic regurgitation who require replacement of their native aortic valve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed Informed Consent
- Age ≥18years of age
- Presents with symptomatic aortic stenosis and/or aortic regurgitation, as well as NYHA rating of NYHA ≥ II
- Has undergone the diagnosis of at least one interventional cardiologist and two cardiac surgeons: the patients are contraindicated for traditional open heart valve replacement surgery (defined as 30 days post-op mortality risk >50%, irreversible complications, or other influential post-operative factors [such as severe calcification in the ascending aorta and aortic valve, weak physical condition, chest deformities, severe liver diseases, severe lung diseases, etc.] or high risk for surgery (LogEuroSCORE≥20% and or STS≥8)
- Has a diagnosis from at least one interventional cardiologist and two cardiac surgeons that the patient may benefit from a valve implantation
Key exclusion criteria (30 listed)
- Patients with infection or who have any sign of infection
- Previous history of endocarditis or patients with active endocarditis
- Incidence of acute myocardial infarction within the past 30 days (Q-wave MI, or non Q-wave MI with creatine kinase, an increase in troponin T)
- Any cardiac mass discovered during echocardiography, left ventricular or atrial thrombosis
- Suffering from uncontrollable atrial fibrillation
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 |
|---|---|---|
| J-Valve Transcatheter Aortic valve replacementAlso: TAVITransapical Transcatheter Aortic Valve Replacement | Device | Single arm observational study |
Primary outcome
All-cause Mortality
Time frame: 12 months
1 secondary outcome
Cardiac function improvement
Time frame: 30 days, 6 months, 12 months and annually up to 5 years
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ji Zhang, MD study director
CEO, President
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing J-Valve Transcatheter Aortic valve replacement in people with Aortic Valve Disease, run by JC Medical, Inc., an affiliate of Edwards Lifesciences LLC at 3 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 11 inclusion and 30 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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 19 Sep 2024.