Aortic InsufficiencyNCT05424653
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency
A study testing Transcatheter Aortic Valve System in people with Aortic Insufficiency, run by Chengdu Silara Meditech Inc..
Trial summary
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Symptomatic Aortic Insufficiency Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Insufficiency
- What is being tested?
- Transcatheter Aortic Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 31 Aug 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years old;
- Subjects with symptomatic severe aortic valve regurgitation.
- NYHA Functional Class ≥II.
- Life expectancy after aortic valve implantation thought to be >1 year，
- Native valvular or peripheral vascular anatomy is appropriate for TAVR.
- Patient is assessed by at least two cardiothoracic surgeons and recorded as not suitable for surgery (defined as a risk of operative mortality after 30 days>50%，or severe irreversible comorbidities or other factors affecting surgery (e.g., porcelain aorta, frailty, chest malformation, severe liver disease, severe lung disease, etc.)), or patients at high risk of surgery（Euroscore≥20%, or STS≥8）,or patient not agree open surgery.
- Patient can understand the purpose of the study, voluntarily participates and signs the informed consent form and is willing to accept the relevant examination and clinical follow-up visits.
Who cannot join
- Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter ≤20mm,or ≥28mm
- Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave myocardial infarction, with CK-MB≥ 2x normal and/or elevated Tn (WHO definition).
- Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization).
- Hematological abnormality, defined as: Leukopenia (WBC <3×109/L), acute anemia (Hb <90g/L), or thrombocytopenia (platelet count<50×109/L), history of bleeding diathesis or coagulopathy.
- Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) <20%.
- Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.
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- Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure.
- Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure,including TIA.
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine , clopidogrel and high polymer material, or sensitivity to contrast media, which cannot be adequately pre-medicated.
- Patients with infective endocarditis or other active stage of infection. Currently participating in an investigational drug or another device trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Symptomatic Aortic Insufficiency
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Symptomatic Aortic Insufficiency
Read the detailed description
Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study. To evaluate the feasibility , safety and effectiveness of Transcatheter aortic valve system.
- Conditions
- Aortic Insufficiency
- Being tested
- Transcatheter Aortic Valve System
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve SystemDevice
Procedure: Transcatheter Aortic Valve Replacement
| Study group | Role | What they receive |
|---|---|---|
| Severe Symptomatic Aortic Regurgitation | Experimental | Patients will be treated with transcatheter aortic valve system Receives: Device: Transcatheter Aortic Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Device success
Device Success is defined as a composite of :
Absence of procedural mortality AND Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system AND Correct positioning of prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (mean aortic valve gradient<20 mmHg or peak velocity<3 m/s, and no moderate or more prosthetic valve regurgitation
Measured: Immediate post- procedure
Rate of Procedure success
Procedure Success is defined as no death, stroke, myocardial infarction and renal failure occurred within 72 hours after the operation on the basis of the final device success.
Measured: Immediate post procedure
Rate of none or trace AR
Measured: 30 days
Rate of All cause mortality,including Cardiac death, non-cardiac death and unexplained death
Percentage of subjects who died from all causes in this population
Measured: 30 days
Incidence of MACCE
MACCE includs death, stroke, MI, re-procedure, conduction disturbances and cardiac arrhythmias
Measured: 30 days
Secondary outcomes (17)
Delivery system performance
Delivery System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.
Measured: Immediate post-procedure
Retrieval system performance (if need)
Retrieval System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.
Measured: Immediate post-procedure
Exchange system evaluation
Exchange Systerm Evaluation wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.
Measured: Immediate post-procedure
Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL
The evaluation criteria refer to the 2012 edition of the Association for Valvular Academic Research (VARC-2) consensus document
Measured: Immediate post-procedure, 7 days or discharge, 30 days, 6 months and 12months
Quality of Life Assessment
SF-12
Measured: 30 days, 6 months,and 12 months
NYHA function
Measured: 7 days or discharge, 30 days, 6 months ,12 months
All-cause Mortality
Measured: Immediate post- procedure ,7 days /discharge, 6 months and 12 months
Rate of moderate to severe AR
Measured: immediate post- procedure ,7 days /discharge, 6 months and 12 months
Incidence of Myocardial Infarction
Measured: immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12months
Incidence of MACCE
including death, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias
Measured: Immediate post- procedure, 7 days /discharge, 6 months and 12months.
Incidence of Bleeding(life-threatening or disabling and major)
Measured: Immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12 months
Incidence of stroke
Measured: 7 days /discharge, 30 days, 6 months and 12 months
Incidence of AKI
including AKIN stage 2 and 3,or renal replacement therapy (RRT:Hemodialysis, abdomen Cavity dialysis, hemofiltration)
Measured: 7 days /discharge, 30 days, 6 months and 12 months
Incidence of Permanent Pacemaker Implantation
Measured: 7 days /discharge, 30 days, 6 months and 12 months
Incidence of major vascular complications
Measured: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months
Incidence of Conduction disturbances and cardiac arrhythmias
Measured: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months
Incidence of other TAVI-related complications
including transfer to surgery , accidental heart-lung machine, coronary obstruction, ventricular septal rupture, mitral valve damage or dysfunction，cardiac tamponade，endocarditis ，valvular thrombus，valve migration(shifting, detachment, embolism, error deployment）,valve in valve
Measured: at immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic InsufficiencyStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Silara Meditech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jincheng Liu, Principal investigator, The First Affiliated Hospital,the Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424653
- Sponsor's protocol ID
- Silara202101
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Symptomatic Aortic Insufficiency
- ClinicalTrials.gov ID
- NCT05424653
- Acronym / sponsor ID
- Silara202101
- Conditions
- Aortic Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chengdu Silara Meditech Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 21 Jun 2022 (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.
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Symptomatic Aortic Insufficiency
Detailed description
Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study. To evaluate the feasibility , safety and effectiveness of Transcatheter aortic valve system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Symptomatic Aortic Regurgitation | Experimental | Device: Transcatheter Aortic Valve SystemPatients will be treated with transcatheter aortic valve system |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 60 years old;
- Subjects with symptomatic severe aortic valve regurgitation.
- NYHA Functional Class ≥II.
- Life expectancy after aortic valve implantation thought to be >1 year，
- Native valvular or peripheral vascular anatomy is appropriate for TAVR.
Key exclusion criteria (10 listed)
- Anatomy is not appropriate for percutaneous valve implantation. Native valve annulus diameter is not in the scope of application(native TAV diameter ≤20mm,or ≥28mm
- Evidence of an acute myocardial infarction within 30 days prior to the study procedure, defined as: Q-wave myocardial infarction, or non-Q-wave myocardial infarction, with CK-MB≥ 2x normal and/or elevated Tn (WHO definition).
- Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization).
- Hematological abnormality, defined as: Leukopenia (WBC <3×109/L), acute anemia (Hb <90g/L), or thrombocytopenia (platelet count<50×109/L), history of bleeding diathesis or coagulopathy.
- Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) <20%.
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 |
|---|---|---|
| Transcatheter Aortic Valve SystemProcedure: Transcatheter Aortic Valve Replacement | Device | Severe Symptomatic Aortic Regurgitation |
Primary outcome
Rate of Device success
Time frame: Immediate post- procedure
Device Success is defined as a composite of : Absence of procedural mortality AND Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system AND Correct positioning of prosthetic heart valve into the proper anatomical location AND Intended performance of the prosthetic heart valve (mean aortic valve gradient<20 mmHg or peak velocity<3 m/s, and no moderate or more prosthetic valve regurgitation
Rate of Procedure success
Time frame: Immediate post procedure
Procedure Success is defined as no death, stroke, myocardial infarction and renal failure occurred within 72 hours after the operation on the basis of the final device success.
Rate of none or trace AR
Time frame: 30 days
Rate of All cause mortality,including Cardiac death, non-cardiac death and unexplained death
Time frame: 30 days
Percentage of subjects who died from all causes in this population
Incidence of MACCE
Time frame: 30 days
MACCE includs death, stroke, MI, re-procedure, conduction disturbances and cardiac arrhythmias
17 secondary outcomes
Delivery system performance
Time frame: Immediate post-procedure
Retrieval system performance (if need)
Time frame: Immediate post-procedure
Exchange system evaluation
Time frame: Immediate post-procedure
Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL
Time frame: Immediate post-procedure, 7 days or discharge, 30 days, 6 months and 12months
Quality of Life Assessment
Time frame: 30 days, 6 months,and 12 months
NYHA function
Time frame: 7 days or discharge, 30 days, 6 months ,12 months
All-cause Mortality
Time frame: Immediate post- procedure ,7 days /discharge, 6 months and 12 months
Rate of moderate to severe AR
Time frame: immediate post- procedure ,7 days /discharge, 6 months and 12 months
Incidence of Myocardial Infarction
Time frame: immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12months
Incidence of MACCE
Time frame: Immediate post- procedure, 7 days /discharge, 6 months and 12months.
Incidence of Bleeding(life-threatening or disabling and major)
Time frame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12 months
Incidence of stroke
Time frame: 7 days /discharge, 30 days, 6 months and 12 months
Incidence of AKI
Time frame: 7 days /discharge, 30 days, 6 months and 12 months
Incidence of Permanent Pacemaker Implantation
Time frame: 7 days /discharge, 30 days, 6 months and 12 months
Incidence of major vascular complications
Time frame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months
Incidence of Conduction disturbances and cardiac arrhythmias
Time frame: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months
Incidence of other TAVI-related complications
Time frame: at immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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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.
Jincheng Liu principal investigator
The First Affiliated Hospital,the Air Force Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Aortic Valve System in people with Aortic Insufficiency, run by Chengdu Silara Meditech 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 7 inclusion and 10 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 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Liu (+86 13519135591, liuyangxijing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Device success (time frame: Immediate post- procedure). The study lists 5 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 21 Jun 2022.