Aortic Valve StenosisVenus-ANCT01683474
Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis
A study testing Venus MedTech Aortic Valve Prosthesis in people with Aortic Valve Stenosis and Aortic Valve Calcification, run by Venus MedTech (HangZhou) Inc. at 1 site in China.
Trial summary
1. objectives Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis. Continuous observe 12 months of safety and efficacy. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Calcification
- What is being tested?
- Venus MedTech Aortic Valve Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Apr 2016
- 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
- Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥ 40 mm Hg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of < 0.8 cm2 (or AVA index < 0.5 cm2/m2)
- Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class ≥ II
- The subject or the subject's legal representative was informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
- The subject agreed to comply follow-up evaluation
- is evaluated by at least one cardiologist and two cardiovascular surgeon, and they agreed that medical factors precluding operation suitable for surgery (the probability of death or serious, irreversible morbidity exceeded 50%)
- STS score ≥ 10%
Who cannot join
- Patient refuses aortic valve replacement surgery.
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days （6 month if DES implant）
- Implanted any heart valve prosthesis, prosthetic valve ring, severe mitral valve ring calcification (MAC), severe（>3＋）mitral valve insufficiency, or Gorelin symptom
Show all 24Show fewer
- Blood dyscrasia such as leukopenia (WBC < 3×109/L), acute anemia (Hgb < 90 g/L), thrombocytopenia (PLT < 50×109/L), bleeding diathesis, or history of coagulopathy.
- Untreated clinically significant coronary artery disease requiring revascularization
- Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices
- Need for emergency surgery for any reason
- Hypertrophic cardiomyopathy with or without obstruction (HOCM)
- Severe ventricular dysfunction with LVEF < 20%
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.
- Native aortic annulus size < 20 mm or> 29 mm as measured by echocardiogram.
- Cerebrovascular Accident (CVA) within 6 months, including TIA.
- Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis.
- Life expectancy < 12 months
- Significant abdominal or thoracic aorta disease, including aneurysm (defined as maximal luminal diameter 5cm or greater), marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding or ulcerated), narrowing of the abdominal aorta (especially with calcification and surface irregularities), or severe "unfolding" and tortuosity of the thoracic aorta
- Iliofemoral vessel characteristics that would preclude safe placement of 16F or 18F introducer sheath such as severe obstructive calcification, severe tortuosity or vessel size diameter < 7 mm.
- Currently participating in an investigational drug or another device study.
- Active bacterial endocarditis or other active infections.
- Bulky calcified aortic valve leaflets in close proximity to coronary ostia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fu Wai Hospital, CAMS & PUMA
Beijing, Beijing Municipality, 100037
Runlin Gao, MD, gaorunlin4study@gmail.com
Runlin Gao, MD
About this study
Official title: Clinical Evaluation of the Safety and Performance of Percutaneous Implantation of the Venus MedTech Aortic Valve Prosthesis for Patients Who Cannot Undergo Surgical Valve Replacement
- objectives
- Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery
- Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Continuous observe 12 months of safety and efficacy.
- Approximately 80 patients presenting with native aortic valve stenosis necessitating valve replacement which are considered unsuitable for Surgical Valve Replacement, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.
- Safety and performance will be evaluated at discharge and at 30 days post procedure. Valve safety, performance and placement will be followed up at 6 and 12 months post-procedure.
Read the detailed description
A prospective OPC study to evaluate its performance and long-term safety and effectiveness of Venus-A aortic valve.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification
- Being tested
- Venus MedTech Aortic Valve Prosthesis
- Keywords
- aortic valve stenosis, Calcification, TAVI, aortic valve Prosthesis
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve, Calcification of, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus MedTech Aortic Valve ProsthesisDevice
Also called Venus A-Valve, Venus A-Valve System
Percutaneous implantation of aortic valve of Venus-A
| Study group | Role | What they receive |
|---|---|---|
| Venus A-Valve | Experimental | single arm with intervention that percutaneous implantation of the Venus MedTech Aortic Valve Prosthesis Receives: Device: Venus MedTech Aortic Valve Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality and major stroke at 12 months post-procedure.
Measured: 12 months post-procedure
Secondary outcomes (1)
Valve performance and placement at 6 and 12 months post-procedure
Measured: 6 and 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Venus MedTech (HangZhou) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruilin Gao, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683474
- Sponsor's protocol ID
- Venus-A Study
- Acronym
- Venus-A
- Status last verified
- Jan 2015
- First submitted
- 7 Sep 2012
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lei WH, Liao YB, Wang ZJ, Ou YW, Tsauo JY, Li YJ, Xiong TY, Zhao ZG, Wei X, Meng W, Feng Y, Chen M. Transcatheter Aortic Valve Replacement in Patients with Aortic Stenosis Having Coronary Cusp Fusion versus Mixed Cusp Fusion Nonraphe Bicuspid Aortic Valve. J Interv Cardiol. 2019 Nov 3;2019:7348964. doi: 10.1155/2019/7348964. eCollection 2019.
PubMed 31777470Liao YB, Li YJ, Xiong TY, Ou YW, Lv WY, He JL, Li YM, Zhao ZG, Wei X, Xu YN, Feng Y, Chen M. Comparison of procedural, clinical and valve performance results of transcatheter aortic valve replacement in patients with bicuspid versus tricuspid aortic stenosis. Int J Cardiol. 2018 Mar 1;254:69-74. doi: 10.1016/j.ijcard.2017.12.013. Epub 2017 Dec 9.
PubMed 29246428Jilaihawi H, Wu Y, Yang Y, Xu L, Chen M, Wang J, Kong X, Zhang R, Wang M, Lv B, Wang W, Xu B, Makkar RR, Sievert H, Gao R. Morphological characteristics of severe aortic stenosis in China: imaging corelab observations from the first Chinese transcatheter aortic valve trial. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:752-61. doi: 10.1002/ccd.25863. Epub 2015 Feb 19.
PubMed 25630494
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Performance of Percutaneous Implantation of the Venus MedTech Aortic Valve Prosthesis for Patients Who Cannot Undergo Surgical Valve Replacement
- ClinicalTrials.gov ID
- NCT01683474
- Acronym / sponsor ID
- Venus-A / Venus-A Study
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification
- Keywords
- aortic valve stenosis, Calcification, TAVI, aortic valve Prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Venus MedTech (HangZhou) Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 11 Sep 2012 (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.
- objectives
- Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery
- Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Continuous observe 12 months of safety and efficacy.
- Approximately 80 patients presenting with native aortic valve stenosis necessitating valve replacement which are considered unsuitable for Surgical Valve Replacement, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.
- Safety and performance will be evaluated at discharge and at 30 days post procedure. Valve safety, performance and placement will be followed up at 6 and 12 months post-procedure.
Detailed description
A prospective OPC study to evaluate its performance and long-term safety and effectiveness of Venus-A aortic valve.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venus A-Valve | Experimental | Device: Venus MedTech Aortic Valve Prosthesissingle arm with intervention that percutaneous implantation of the Venus MedTech Aortic Valve Prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥ 40 mm Hg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of < 0.8 cm2 (or AVA index < 0.5 cm2/m2)
- Symptomatic due to aortic valve stenosis as demonstrated by NYHA Functional Class ≥ II
- The subject or the subject's legal representative was informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board of the respective clinical site.
- The subject agreed to comply follow-up evaluation
- is evaluated by at least one cardiologist and two cardiovascular surgeon, and they agreed that medical factors precluding operation suitable for surgery (the probability of death or serious, irreversible morbidity exceeded 50%)
Key exclusion criteria (24 listed)
- Patient refuses aortic valve replacement surgery.
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days （6 month if DES implant）
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 MedTech Aortic Valve ProsthesisAlso: Venus A-Valve, Venus A-Valve SystemPercutaneous implantation of aortic valve of Venus-A | Device | Venus A-Valve |
Primary outcome
All cause mortality and major stroke at 12 months post-procedure.
Time frame: 12 months post-procedure
1 secondary outcome
Valve performance and placement at 6 and 12 months post-procedure
Time frame: 6 and 12 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Derived from this study: PubMed 31777470Lei WH, Liao YB, Wang ZJ, Ou YW, Tsauo JY, Li YJ, Xiong TY, Zhao ZG, Wei X, Meng W, Feng Y, Chen M. Transcatheter Aortic Valve Replacement in Patients with Aortic Stenosis Having Coronary Cusp Fusion versus Mixed Cusp Fusion Nonraphe Bicuspid Aortic Valve. J Interv Cardiol. 2019 Nov 3;2019:7348964. doi: 10.1155/2019/7348964. eCollection 2019.
- Derived from this study: PubMed 29246428Liao YB, Li YJ, Xiong TY, Ou YW, Lv WY, He JL, Li YM, Zhao ZG, Wei X, Xu YN, Feng Y, Chen M. Comparison of procedural, clinical and valve performance results of transcatheter aortic valve replacement in patients with bicuspid versus tricuspid aortic stenosis. Int J Cardiol. 2018 Mar 1;254:69-74. doi: 10.1016/j.ijcard.2017.12.013. Epub 2017 Dec 9.
- Derived from this study: PubMed 25630494Jilaihawi H, Wu Y, Yang Y, Xu L, Chen M, Wang J, Kong X, Zhang R, Wang M, Lv B, Wang W, Xu B, Makkar RR, Sievert H, Gao R. Morphological characteristics of severe aortic stenosis in China: imaging corelab observations from the first Chinese transcatheter aortic valve trial. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:752-61. doi: 10.1002/ccd.25863. Epub 2015 Feb 19.
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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.
Ruilin Gao, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
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 MedTech Aortic Valve Prosthesis in people with Aortic Valve Stenosis and Aortic Valve Calcification, run by Venus MedTech (HangZhou) Inc. at 1 site 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 6 inclusion and 24 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 6 Jan 2015. 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 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?
Contact Runlin Gao, MD (88398866 ext. 8266, gaorunlin4study@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality and major stroke at 12 months post-procedure. (time frame: 12 months post-procedure). 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 NCT01683474, which also lists 3 linked publications.
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 6 Jan 2015.