Aortic Valve StenosisNCT04893603
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis
A study testing Transcatheter Aortic Valve System in people with Aortic Valve Stenosis, run by Chengdu Silara Meditech Inc. at 1 site in China.
Trial summary
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- 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
- 120 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2020to 31 Dec 2026
- Phase
- Interventional
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥70 years old;
- Symptomatic severe aortic stenosis determined by echocardiogram, defined as: mean gradient ≥40 mmHg or peak jet velocity ≥4.0 m/s, or an aortic valve area <0.8 cm2 or aortic valve area index <0.5 cm2/m2.
- 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;
- 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 ≤21mm, or ≥30mm);
- 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≥2 ULN/or elevated TN (WHO definition);
- Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization);
- Pre-existing prosthetic valve in any position(except severely dysfunctional aortic bioprosthesis), or severe (>3+) mitral insufficiency, or Gorlin syndrome;
- Hematological abnormality, defined as: Leukopenia (WBC <3x10^9/L), acute anemia (Hb <90g/L), or thrombocytopenia (platelet count<50×109/L),history of bleeding diathesis or coagulopathy;
- Hemodynamic unstable requiring myocardial contractile support or mechanical cardiac assistance;
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- Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) <20%;
- Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.;
- 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 or clopidogrel, 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, CAMS&PUMC
Beijing
Yongjian Wu
Runlin Gao
About this study
Official title: A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis With or Without Moderate or Lower Degree Regurgitation
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation
Read the detailed description
Transcatheter Aortic Valve System (Chengdu Silara Medtech Inc. ,Chengdu, China) will be used for this study.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Transcatheter Aortic 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.
Transcatheter Aortic Valve SystemDevice
Procedure: Transcatheter aortic valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Severe Aortic Valve Stenosis | Experimental | Patients will be treated with Transcatheter Aortic Valve Systerm 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 All-cause Mortality
Percentage of subjects who died from all causes in this population.
Measured: 12 months
Secondary outcomes (18)
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 severe prosthetic valve regurgitation or PVL)
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
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 using)
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 Systerm 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, 7days or discharge, 30 days, 6 months ,12months and 2-5 years
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 and 2-5 years
Rate of All-cause Mortality
Measured: Immediate post- procedure ,7 days /discharge, 30 days, 6 months and 2-5 years.
Incidence of Myocardial Infarction
Measured: Immediate post- procedure, 7 days /discharge, 30 days, 6 months ,12months and 2-5 years.
Incidence of MACCE(including mortality, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias)
Measured: Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.
Incidence of Bleeding (life-threatening or disabling and major)
Measured: Immediate post- procedure, 7 days /discharge, 30 days, 6 months,12months and 2-5 years.
Incidence of Stroke
Measured: 7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
Incidence of AKI (stage 2 and 3,or renal replacement therapy (RRT: Hemodialysis, abdomen Cavity dialysis, hemofiltration))
Measured: 7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
Incidence of Permanent Pacemaker Implantation
Measured: 7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.
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 month and 2-5years
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: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start16 Dec 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2026 (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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Silara Meditech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongjian Wu, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893603
- Sponsor's protocol ID
- Silara201901
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2021
- Last updated
- 19 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No