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To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency

Primary Purpose

Aortic Insufficiency

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcatheter Aortic Valve System
Sponsored by
Chengdu Silara Meditech Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Insufficiency

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 60 years old;
  2. Subjects with symptomatic severe aortic valve regurgitation.
  3. NYHA Functional Class ≥II.
  4. Life expectancy after aortic valve implantation thought to be >1 year,
  5. Native valvular or peripheral vascular anatomy is appropriate for TAVR.
  6. 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.
  7. 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.

Exclusion Criteria:

  1. 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
  2. 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).
  3. Any treatment for traumatic cardiac surgery within 30 day prior to the study procedure(except coronary revascularization).
  4. 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.
  5. Severe ventricular insufficiency. Left ventricular ejection fraction (LVEF) <20%.
  6. Echocardiographic evidence of intra-cardiac thrombus or vegetation etc.
  7. Active pepticulcer or upper GI bleeding within 3 months prior to the study procedure.
  8. Cerebral Vascular Accident (CVA) within 3 months prior to the study procedure,including TIA.
  9. 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.
  10. Patients with infective endocarditis or other active stage of infection. Currently participating in an investigational drug or another device trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Severe Symptomatic Aortic Regurgitation

    Arm Description

    Patients will be treated with transcatheter aortic valve system

    Outcomes

    Primary Outcome Measures

    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
    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.
    Rate of none or trace AR
    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
    Incidence of MACCE
    MACCE includs death, stroke, MI, re-procedure, conduction disturbances and cardiac arrhythmias

    Secondary Outcome Measures

    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.
    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.
    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.
    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
    Quality of Life Assessment
    SF-12
    NYHA function
    All-cause Mortality
    Rate of moderate to severe AR
    Incidence of Myocardial Infarction
    Incidence of MACCE
    including death, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias
    Incidence of Bleeding(life-threatening or disabling and major)
    Incidence of stroke
    Incidence of AKI
    including AKIN stage 2 and 3,or renal replacement therapy (RRT:Hemodialysis, abdomen Cavity dialysis, hemofiltration)
    Incidence of Permanent Pacemaker Implantation
    Incidence of major vascular complications
    Incidence of Conduction disturbances and cardiac arrhythmias
    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

    Full Information

    First Posted
    June 15, 2022
    Last Updated
    June 15, 2022
    Sponsor
    Chengdu Silara Meditech Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05424653
    Brief Title
    To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency
    Official Title
    To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Symptomatic Aortic Insufficiency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    August 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chengdu Silara Meditech Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Insufficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Severe Symptomatic Aortic Regurgitation
    Arm Type
    Experimental
    Arm Description
    Patients will be treated with transcatheter aortic valve system
    Intervention Type
    Device
    Intervention Name(s)
    Transcatheter Aortic Valve System
    Intervention Description
    Procedure: Transcatheter Aortic Valve Replacement
    Primary Outcome Measure Information:
    Title
    Rate of Device success
    Description
    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
    Time Frame
    Immediate post- procedure
    Title
    Rate of Procedure success
    Description
    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.
    Time Frame
    Immediate post procedure
    Title
    Rate of none or trace AR
    Time Frame
    30 days
    Title
    Rate of All cause mortality,including Cardiac death, non-cardiac death and unexplained death
    Description
    Percentage of subjects who died from all causes in this population
    Time Frame
    30 days
    Title
    Incidence of MACCE
    Description
    MACCE includs death, stroke, MI, re-procedure, conduction disturbances and cardiac arrhythmias
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Delivery system performance
    Description
    Delivery System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.
    Time Frame
    Immediate post-procedure
    Title
    Retrieval system performance (if need)
    Description
    Retrieval System Performance wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.
    Time Frame
    Immediate post-procedure
    Title
    Exchange system evaluation
    Description
    Exchange Systerm Evaluation wil be evaluated subjectively by the researchers participating in the operation, which is generally classified as excellent, good ,average and poor.
    Time Frame
    Immediate post-procedure
    Title
    Valvular function evaluation, including valve stenosis, AR, valve function(e.g. EOA, gradient) and PVL
    Description
    The evaluation criteria refer to the 2012 edition of the Association for Valvular Academic Research (VARC-2) consensus document
    Time Frame
    Immediate post-procedure, 7 days or discharge, 30 days, 6 months and 12months
    Title
    Quality of Life Assessment
    Description
    SF-12
    Time Frame
    30 days, 6 months,and 12 months
    Title
    NYHA function
    Time Frame
    7 days or discharge, 30 days, 6 months ,12 months
    Title
    All-cause Mortality
    Time Frame
    Immediate post- procedure ,7 days /discharge, 6 months and 12 months
    Title
    Rate of moderate to severe AR
    Time Frame
    immediate post- procedure ,7 days /discharge, 6 months and 12 months
    Title
    Incidence of Myocardial Infarction
    Time Frame
    immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12months
    Title
    Incidence of MACCE
    Description
    including death, stroke, MI, re-procedure, Conduction disturbances and cardiac arrhythmias
    Time Frame
    Immediate post- procedure, 7 days /discharge, 6 months and 12months.
    Title
    Incidence of Bleeding(life-threatening or disabling and major)
    Time Frame
    Immediate post- procedure, 7 days /discharge, 30 days, 6 months and 12 months
    Title
    Incidence of stroke
    Time Frame
    7 days /discharge, 30 days, 6 months and 12 months
    Title
    Incidence of AKI
    Description
    including AKIN stage 2 and 3,or renal replacement therapy (RRT:Hemodialysis, abdomen Cavity dialysis, hemofiltration)
    Time Frame
    7 days /discharge, 30 days, 6 months and 12 months
    Title
    Incidence of Permanent Pacemaker Implantation
    Time Frame
    7 days /discharge, 30 days, 6 months and 12 months
    Title
    Incidence of major vascular complications
    Time Frame
    Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months
    Title
    Incidence of Conduction disturbances and cardiac arrhythmias
    Time Frame
    Immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 months
    Title
    Incidence of other TAVI-related complications
    Description
    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
    Time Frame
    at immediate post- procedure, 7 days /discharge, 30 days, 6 months, 12 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yang Liu
    Phone
    +86 13519135591
    Email
    liuyangxijing@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jincheng Liu
    Organizational Affiliation
    The First Affiliated Hospital,the Air Force Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency

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