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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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 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.

Moyang Wang contact

(86)-010-68314466

wangmoyang1983@vip.sina.com

China1 site, 1 recruiting

  • Fuwai Hospital, CAMS&PUMC

    Beijing

    Yongjian Wu

    Runlin Gao

    Recruiting

Other trials in China

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.

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 groups in NCT04893603
Study groupRoleWhat they receive
Severe Aortic Valve StenosisExperimentalPatients 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.

  1. Rate of All-cause Mortality

    Percentage of subjects who died from all causes in this population.

    Measured: 12 months

Secondary outcomes (18)

  1. Rate of Device Success

    Device Success is defined as a composite of :

    1. Absence of procedural mortality AND
    2. Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system AND
    3. Correct positioning of prosthetic heart valve into the proper anatomical location AND
    4. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Quality of Life Assessment

    SF-12

    Measured: 30 days, 6 months,and 12 months

  8. NYHA function

    Measured: 7 days or discharge, 30 days, 6 months ,12 months and 2-5 years

  9. Rate of All-cause Mortality

    Measured: Immediate post- procedure ,7 days /discharge, 30 days, 6 months and 2-5 years.

  10. Incidence of Myocardial Infarction

    Measured: Immediate post- procedure, 7 days /discharge, 30 days, 6 months ,12months and 2-5 years.

  11. 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.

  12. 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.

  13. Incidence of Stroke

    Measured: 7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.

  14. 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.

  15. Incidence of Permanent Pacemaker Implantation

    Measured: 7 days /discharge, 30 days, 6 months, 12 months and 2-5 years.

  16. Incidence of major vascular complications

    Measured: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months.

  17. Incidence of Conduction disturbances and cardiac arrhythmias

    Measured: Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month and 2-5years

  18. 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.

  1. First posted19 May 2021
  2. Study start16 Dec 2020
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter Aortic Valve System in people with Aortic Valve Stenosis, run by Chengdu Silara Meditech 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 19 May 2021. 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?

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 Moyang Wang ((86)-010-68314466, wangmoyang1983@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of All-cause Mortality (time frame: 12 months). 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 NCT04893603.

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 19 May 2021.

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