Aortic Valve DiseaseNCT02221921
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
A study testing MicroPort's Transcatheter Aortic Valve and Delivery System in people with Aortic Valve Disease and Aortic Valve Stenosis, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for Surgical Valve Replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification
- What is being tested?
- MicroPort's Transcatheter Aortic Valve and Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Sep 2021
- 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
- 18 years or older, male or non pregnant women;
- Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥ 40 mmHg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of < 1.0 cm2 (or AVA index < 0.6 cm2/m2)
- Symptomatic due to aortic valve stenosis as demonstrated by NYHA (New York Heart Association) Functional Class ≥ II
- Expectation of life>12 months
- Calcific aortic stenosis, which is suitable for transcatheter aortic valve implantation anatomically
- is evaluated by at least two cardiovascular physicians, and they agreed that medical factors precluding operation suitable for surgery (the probability of death or serious, irreversible morbidity exceeded 50%)
- The subject agreed to comply follow-up evaluation
Who cannot join
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
- aortic valve is a congenital unicuspid valve, or is non-calcified.
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days
- Implanted any heart valve prosthesis, prosthetic valve ring, severe（>3＋）mitral valve insufficiency
- 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
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- Hemodynamic instability requiring mechanical cardiac assist or mechanical hemodynamic support devices
- Need for emergency surgery for any reason
- Hypertrophic cardiomyopathy with or without obstruction
- Severe ventricular dysfunction with LVEF (Left ventricular ejection fraction) < 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 < 17 mm or> 29 mm.
- Patient refuses aortic valve replacement surgery.
- Cerebrovascular Accident (CVA) within 6 months, including TIA (transient ischemic attack).
- 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, marked tortuosity (hyperacute bend), aortic arch atheroma, 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 to 19F introducer sheath such as severe obstructive calcification, severe tortuosity
- Active bacterial endocarditis or other active infections.
- Bulky calcified aortic valve leaflets in close proximity to coronary ostia
- severe incapacitating dementia.
- Currently participating in an investigational drug or another device study that has not reached its primary endpoint.
- Researchers identify that the patients with poor compliance who cannot be completed in accordance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Safety and Performance of the MicroPort's Transcatheter Aortic Valve and Delivery System for Treatment of Severe Aortic Stenosis
The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for Surgical Valve Replacement.
Read the detailed description
- Evaluate the performance, safety and clinical benefit of MicroPort's aortic valve prosthesis and delivery system in intervention by peripheral artery.
- The study Continuous observe 12 months of safety and efficacy. Approximately 89 patients are recruited in the study with native aortic valve stenosis which are considered unsuitable for Surgical Valve Replacement.
- Being tested
- MicroPort's Transcatheter Aortic Valve and Delivery System
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroPort's Transcatheter Aortic Valve and Delivery SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| MicroPort's Transcatheter Aortic Valve and Delivery System | Experimental | single arm with intervention that percutaneous implantation of the MicroPort's Transcatheter Aortic Valve and Delivery System Receives: Device: MicroPort's Transcatheter Aortic Valve and Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality or major stroke at 12 months.
Measured: 12 months
Secondary outcomes (4)
MACCE(major adverse cardiovascular and cerebrovascular events)
MACCE is defined as a composite of:
- Myocardial infarction (MI)
- Hemorrhage
- renal failure
- vascular complications
- block
- ventricular arrhythmias
Measured: 30 days, 3, 6 and 12 months
Device success
Device success is defined as
- The device successfully enter the vascular approach, transport and release
- The valve is placed in the correct anatomical position
- The valve achieve the expected effect (mean aortic pressure < 20mmHg or peak velocity < 3m/s, with no severe aortic regurgitation or paravalvular leakage)
Measured: 7 days post-operation
Valve performance
Valve performance means:
- Transvalvular mean gradient
- Effective orifice area
- Degree of aortic valve regurgitation (transvalvular and paravalvular)
Measured: 30 days, 3, 6 and 12 months
The improvement of heart function
Measured: 30 days, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2021 (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
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JunBo Ge, Medical Doctor, Professor, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221921
- Sponsor's protocol ID
- U0000SYV
- Other IDs
- MicroPort Medical
- Status last verified
- Aug 2014
- First submitted
- 14 Aug 2014
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Performance of the MicroPort's Transcatheter Aortic Valve and Delivery System for Treatment of Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT02221921
- Acronym / sponsor ID
- U0000SYV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 21 Aug 2014 (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.
The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for Surgical Valve Replacement.
Detailed description
- Evaluate the performance, safety and clinical benefit of MicroPort's aortic valve prosthesis and delivery system in intervention by peripheral artery.
- The study Continuous observe 12 months of safety and efficacy. Approximately 89 patients are recruited in the study with native aortic valve stenosis which are considered unsuitable for Surgical Valve Replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MicroPort's Transcatheter Aortic Valve and Delivery System | Experimental | Device: MicroPort's Transcatheter Aortic Valve and Delivery Systemsingle arm with intervention that percutaneous implantation of the MicroPort's Transcatheter Aortic Valve and Delivery System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older, male or non pregnant women;
- Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥ 40 mmHg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of < 1.0 cm2 (or AVA index < 0.6 cm2/m2)
- Symptomatic due to aortic valve stenosis as demonstrated by NYHA (New York Heart Association) Functional Class ≥ II
- Expectation of life>12 months
- Calcific aortic stenosis, which is suitable for transcatheter aortic valve implantation anatomically
Key exclusion criteria (25 listed)
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
- aortic valve is a congenital unicuspid valve, or is non-calcified.
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days
- Implanted any heart valve prosthesis, prosthetic valve ring, severe（>3＋）mitral valve insufficiency
- 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.
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 |
|---|---|---|
| MicroPort's Transcatheter Aortic Valve and Delivery System | Device | MicroPort's Transcatheter Aortic Valve and Delivery System |
Primary outcome
All cause mortality or major stroke at 12 months.
Time frame: 12 months
4 secondary outcomes
MACCE(major adverse cardiovascular and cerebrovascular events)
Time frame: 30 days, 3, 6 and 12 months
Device success
Time frame: 7 days post-operation
Valve performance
Time frame: 30 days, 3, 6 and 12 months
The improvement of heart function
Time frame: 30 days, 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
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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.
JunBo Ge, Medical Doctor, Professor principal investigator
Shanghai Zhongshan 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 MicroPort's Transcatheter Aortic Valve and Delivery System in people with Aortic Valve Disease and Aortic Valve Stenosis, run by Shanghai MicroPort Medical (Group) Co., Ltd. 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 7 inclusion and 25 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 21 Aug 2014. 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 David Liu, Medical Doctor (+86 13911002920, davidliu@coremed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality or major stroke at 12 months. (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 21 Aug 2014.