Aortic Valve DiseaseMETASARNCT05941455
A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
A study testing Venus-Neo Surgical Aortic Valve in people with Aortic Valve Disease and Cardiovascular Diseases, run by Jilin Venus Haoyue Medtech Limited at 1 site in Germany.
Trial summary
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Cardiovascular Diseases
- What is being tested?
- Venus-Neo Surgical Aortic Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteGermany
- Study dates
- 31 Oct 2023to 31 Oct 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 who are clinically indicated for aortic valve replacement
- Patients who are willing and able to participate in the follow-up requirements, and provide written informed consent
Who cannot join
- Previous surgical or/and transcatheter cardiac valve replacement at any site
- Previous open-heart surgical valve repair at any site
- Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days
- Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention
- Untreated clinically significant coronary artery diseases requiring revascularization
- Acute myocardial infarct within the previous 30 days
Show all 27Show fewer
- Severe right heart dysfunction
- Active infection requiring antibiotic therapy including infective endocarditis
- Hypertrophic obstructive cardiomyopathy (HOCM)
- Severe symptomatic carotid artery stenosis
- Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
- Chronic kidney disease (eGFR<45 mL/min/1.73m2) or end-stage renal disease requiring chronic dialysis
- Hematologic 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 Hematooncology specialists
- Severe chronic lung disease
- Previous organ transplant or currently an organ transplant candidate Anatomical
- LVEF < 20%
- Left ventricular end diastolic diameter (LVEDD) >70mm
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Native aortic valve geometry and size unfavorable for study bioprosthetic valve General
- Hemodynamics instability requiring inotropic support or intra-aortic balloon pump (IABP) or other hemodynamic support device, or any mechanical heart assistance
- Urgent, emergency or salvage surgeries
- Known intolerance for periprocedural/post-procedural anticoagulation or antiplatelet therapy leading to be unable to undergo index procedure per physicians' judgement
- Life expectancy ≤ 1 year due to non-cardiac reasons
- Planned relevant concomitant procedure within 30 days post index procedure
- Current or recent participation (within 6 weeks prior to index procedure) in another drug or device trial
- Pregnant, breastfeeding or intend to become pregnant within 1 year
- Currently incarcerated or unable to give voluntary informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Deutsches Herzzentrum Berlin-Charité
Berlin, 13353
Destino
Volkmar Falk
About this study
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.
Read the detailed description
This is a prospective, multicenter, non-randomized interventional study to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve. 155 subjects are estimated to be enrolled in this study. Total enrollment period for this trial is estimated to be 1 year. Follow-up duration is estimated to be 5 years. Overall duration of the trial is estimated to be 6 years. The trial begins with the enrollment of the first subject and ends after the last subject is exited from the trial after completing the last follow-up visit at approximately 5 years, all subjects are fully monitored, all outstanding data queries are resolved.
- Conditions
- Aortic Valve Disease, Cardiovascular Diseases
- Being tested
- Venus-Neo Surgical Aortic Valve
- Keywords
- Heart Failure, Surgical Cardiovascular Devices
- Medical subject headings
- Aortic Valve Disease, Cardiovascular Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus-Neo Surgical Aortic ValveDevice
Implant of a Venus-Neo Surgical Aortic Valve
| Study group | Role | What they receive |
|---|---|---|
| Venus-Neo group | Experimental | Procedure: surgical aortic valve replacement Receives: Device: Venus-Neo Surgical Aortic Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary composite safety endpoint
composite safety endpoint at 1 year, including: valve-related mortality, thromboembolism, aortic valve reintervention, structural valve deterioration, major paravalvular leak (defined as moderate or greater paravalvular leak or any paravalvular leak requiring intervention), valve thrombosis, endocarditis
Measured: 1 year
Secondary outcomes (2)
secondary composite safety endpoint
safety is assessed over 1-year timeframe by comparing the occurrence of specific safety endpoints to the objective performance criteria (OPC) reported in Table I.1 in "ISO:5840-2:2021(E), Annex I, Methods of evaluating clinical data against objective performance criteria"
Measured: 2 through 5 Years
Occurrence of each of the following adverse events
Occurrence of each of the following adverse events until 5 years, including: mortality, valve-related mortality, thromboembolism, aortic valve reintervention, structural valve deterioration, non-structural valve deterioration, all paravalvular leak, major paravalvular leak, valve thrombosis, endocarditis, all hemorrhage, major hemorrhage, bioprosthetic valve explant, hemolysis
Measured: baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start31 Oct 2023 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 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 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
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jilin Venus Haoyue Medtech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Volkmar Falk, Principal investigator, Deutsches Herzzentrum Berlin-Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941455
- Sponsor's protocol ID
- VSAF-23-02
- Acronym
- METASAR
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to publish the results
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
- ClinicalTrials.gov ID
- NCT05941455
- Acronym / sponsor ID
- METASAR / VSAF-23-02
- Conditions
- Aortic Valve Disease, Cardiovascular Diseases
- Keywords
- Heart Failure, Surgical Cardiovascular Devices
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Jilin Venus Haoyue Medtech LimitedIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 12 Jul 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 goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.
Detailed description
This is a prospective, multicenter, non-randomized interventional study to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve. 155 subjects are estimated to be enrolled in this study. Total enrollment period for this trial is estimated to be 1 year. Follow-up duration is estimated to be 5 years. Overall duration of the trial is estimated to be 6 years. The trial begins with the enrollment of the first subject and ends after the last subject is exited from the trial after completing the last follow-up visit at approximately 5 years, all subjects are fully monitored, all outstanding data queries are resolved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venus-Neo group | Experimental | Device: Venus-Neo Surgical Aortic ValveProcedure: surgical aortic valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients who are clinically indicated for aortic valve replacement
- Patients who are willing and able to participate in the follow-up requirements, and provide written informed consent
Key exclusion criteria (27 listed)
- Previous surgical or/and transcatheter cardiac valve replacement at any site
- Previous open-heart surgical valve repair at any site
- Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days
- Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention
- Untreated clinically significant coronary artery diseases 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-Neo Surgical Aortic ValveImplant of a Venus-Neo Surgical Aortic Valve | Device | Venus-Neo group |
Primary outcome
primary composite safety endpoint
Time frame: 1 year
composite safety endpoint at 1 year, including: valve-related mortality, thromboembolism, aortic valve reintervention, structural valve deterioration, major paravalvular leak (defined as moderate or greater paravalvular leak or any paravalvular leak requiring intervention), valve thrombosis, endocarditis
2 secondary outcomes
secondary composite safety endpoint
Time frame: 2 through 5 Years
Occurrence of each of the following adverse events
Time frame: baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter
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 12 Jul 2023.
- Individual participant dataSharing planned: No. to publish the results
Related trials for Aortic Valve Disease
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
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
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
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.
Volkmar Falk principal investigator
Deutsches Herzzentrum Berlin-Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venus-Neo Surgical Aortic Valve in people with Aortic Valve Disease and Cardiovascular Diseases, run by Jilin Venus Haoyue Medtech Limited at 1 site in Germany.
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 3 inclusion and 27 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 12 Jul 2023. 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 Germany. 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?
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?
Contact Destino (+493045932260, nadia.destino@dhzc-charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary composite safety endpoint (time frame: 1 year). 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 12 Jul 2023.