Aortic Valve StenosisNCT05991271
Venus-Vitae Pivotal Study Smart-Align Study
A study testing Venus-Vitae Transcatheter Heart Valve System in people with Aortic Valve Stenosis, run by Venus MedTech (HangZhou) Inc..
Trial summary
The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Venus-Vitae Transcatheter Heart Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2023to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Patients with the symptoms of severe aortic stenosis
- Severe aortic stenosis (AS, grade 3+), defined as AVA ≤ 1 cm2 (AVAi ≤ 0.6 cm2/m3) or Vmax ≥ 4.0 m/s or MPG ≥ 40 mmHg determined by echocardiography
- Patients deemed for cardiac intervention by a heart team
- Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories.
- Patients or their legal reprensentatives are willing to participate in the study and provide written informed consent, and agree to follow the follow-up requirements
Who cannot join
- A subject meeting any of the following criteria shall be excluded:
- Co-morbidities
- Previous mechanical or biological aortic valve replacement
- Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention
- Acute myocardial infact within 30 days prior to index procedure
- Untreated clinical significant coronary artery disease requiring revascularization
Show all 22Show fewer
- Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent/scaffold implant within 6 months)
- Sever symptomatic carotid artery stenosis
- Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
- Chronic kidney disease (eGFR<30 mL/min/1.73m2)
- Haemotologic disorders: Leukopenia (WBC < 3000 cell/mL), anemia (Hgb < 9 g/dL), thrombocytopenia (Plt< 50,000 cell/mL), or any known blood clotting disorder, deemed clinically significant after consultation with Haematooncology specialists
- Severe right heart dysfunction Anatomical
- LVEF < 20%
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Inappropriate anatomy for femoral introduction and delivery of study device
- Native aortic valve geometry and size unfavorable for study device anchoring General
- Haemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
- Known hypersensitivity or contraindication to antiplatelet, antithrombotic medications, or cobalt-chromium leading to be unable to undergo index procedure per physicians' judgement
- Life expectancy ≤ 1 year due to noncardiac reasons
- Active infection requiring antibiotic therapy including infective endocarditis
- Planned relevant concomitant procedure within 30 days post index procedure
- Pregnant, breastfeeding or intend to become pregnant within 1 year
About this study
Official title: Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System
The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
Read the detailed description
This trial is a prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. Clinical visits will be scheduled at screening, pre-discharge, 30 days, 6 months, 12 months and annually thereafter to 5 years.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Venus-Vitae Transcatheter Heart Valve 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.
Venus-Vitae Transcatheter Heart Valve SystemDevice
The Venus-Vitae THV is comprised of balloon-expandable and radiopaque cobalt-chromium alloy frame, porcine pericardium tri-leaflet, porcine pericardium inner skirt, polyurethane outer skirt, PTFE assembly sutures, and three radiopaque gold markers (Figure 1). The valve utilizes Venus Endura technology and stored in a non-aqueous condition.
| Study group | Role | What they receive |
|---|---|---|
| procedure | Experimental | implant valve by TAVR Receives: Device: Venus-Vitae Transcatheter Heart Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of deaths at the one-year follow-up visit post procedure
All-cause mortality (The rate of deaths at the one-year follow-up visit post procedure)
Measured: 1 Years
Acceptable Hemodynamic Performance at 30 days
Acceptable Bio-prosthesis Hemodynamic Performance at 30 days, defined as:
- Mean gradient < 20mmHg
- Less than moderate aortic regurgitation (perivalvular and transvalvular)
Measured: 30 Days
Secondary outcomes (8)
Occurrence of the following adverse events echocardiogram during follow-up
Occurrence of the following adverse events echocardiogram during follow-up (The rate of follow events during the follow-up)
- All-cause mortality
- All stroke
- Life-threatening bleeding
- Acute MI
- Heart failure hospitalizations
- New permanent pacemaker implantation
- Major vascular complication
- Acute kidney injury
- Aortic valve re-intervention (surgical or transcatheter)
- Valve thrombosis
- Structural valve deterioration
Measured: 5 Years
Technical success is defined as the following
Technical success (at exit from procedure room) (VARC-3[1]) (The rate of Technical success at the Procedure)
- Freedom from mortality
- Successful access, delivery of the device, and retrieval of the delivery system
- Correct positioning of a single prosthetic heart valve into the proper anatomical location
- Freedom from surgery or intervention related to the device or a major vascular or access-related, or cardiac structural complication
Measured: During the Procedure
The rate of device success is defined as the following
Device success (in-hospital) (VARC-3[1]) (The rate of device success during the in-hospital)
- Freedom from mortality
- Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication
- Intended performance of the valve (mean gradient < 20 mmHg, peak velocity <3 m/s, and less than moderate aortic regurgitation)
Measured: Up to 1 week
The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:
Acceptable valve function at pre-discharge by echocardiogram (The rate of follow events during the follow-up)
- Freedom from moderate or greater patient-prosthesis mismatch (PPM)
- MPG <20mmHg
- Freedom from moderate or greater regurgitation (transvalvular and paravalvular)
- Freedom from reoperation or intervention
Measured: Up to 1 week
The rate of freedom from severe coronary overlap assessed by post-implant angiogram
Freedom from severe coronary overlap assessed by post-implant angiogram
Measured: immediately after the procedure
The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT
Freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT (post-implant 30-day CT scan is not mandatory for each subjects)
Measured: 30-Days
The rate of freedom from mild or greater PVL by echocardiogram during follow-up
Freedom from mild or greater PVL by echocardiogram during follow-up
Measured: 5 Years
New York Heart Association (NYHA) classification during follow-up
New York Heart Association (NYHA) classification during follow-up
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start31 Oct 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus MedTech (HangZhou) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991271
- Sponsor's protocol ID
- VTAR-23-03
- Status last verified
- Aug 2023
- First submitted
- 26 Jun 2023
- Last updated
- 18 Aug 2023
- 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 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System
- ClinicalTrials.gov ID
- NCT05991271
- Acronym / sponsor ID
- VTAR-23-03
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Venus MedTech (HangZhou) Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 14 Aug 2023 (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 is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
Detailed description
This trial is a prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. Clinical visits will be scheduled at screening, pre-discharge, 30 days, 6 months, 12 months and annually thereafter to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| procedure | Experimental | Device: Venus-Vitae Transcatheter Heart Valve Systemimplant valve by TAVR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Patients with the symptoms of severe aortic stenosis
- Severe aortic stenosis (AS, grade 3+), defined as AVA ≤ 1 cm2 (AVAi ≤ 0.6 cm2/m3) or Vmax ≥ 4.0 m/s or MPG ≥ 40 mmHg determined by echocardiography
- Patients deemed for cardiac intervention by a heart team
- Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories.
Key exclusion criteria (22 listed)
- Co-morbidities
- Previous mechanical or biological aortic valve replacement
- Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention
- Acute myocardial infact within 30 days prior to index procedure
- Untreated clinical significant coronary artery disease requiring revascularization
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 |
|---|---|---|
| Venus-Vitae Transcatheter Heart Valve SystemThe Venus-Vitae THV is comprised of balloon-expandable and radiopaque cobalt-chromium alloy frame, porcine pericardium tri-leaflet, porcine pericardium inner skirt, polyurethane outer skirt, PTFE assembly sutures, and three radiopaque gold markers (Figure 1). The valve utilizes Venus Endura technology and stored in a non-aqueous condition. | Device | procedure |
Primary outcome
The rate of deaths at the one-year follow-up visit post procedure
Time frame: 1 Years
All-cause mortality (The rate of deaths at the one-year follow-up visit post procedure)
Acceptable Hemodynamic Performance at 30 days
Time frame: 30 Days
Acceptable Bio-prosthesis Hemodynamic Performance at 30 days, defined as: * Mean gradient < 20mmHg * Less than moderate aortic regurgitation (perivalvular and transvalvular)
8 secondary outcomes
Occurrence of the following adverse events echocardiogram during follow-up
Time frame: 5 Years
Technical success is defined as the following
Time frame: During the Procedure
The rate of device success is defined as the following
Time frame: Up to 1 week
The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:
Time frame: Up to 1 week
The rate of freedom from severe coronary overlap assessed by post-implant angiogram
Time frame: immediately after the procedure
The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT
Time frame: 30-Days
The rate of freedom from mild or greater PVL by echocardiogram during follow-up
Time frame: 5 Years
New York Heart Association (NYHA) classification during follow-up
Time frame: 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Venus-Vitae Transcatheter Heart Valve System in people with Aortic Valve Stenosis, run by Venus MedTech (HangZhou) Inc..
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 6 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: opening soon, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
The rate of deaths at the one-year follow-up visit post procedure (time frame: 1 Years). The study lists 2 primary outcomes in all. 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 18 Aug 2023.