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
About this trial
This is an interventional treatment trial for Aortic Insufficiency
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.
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
NCT ID
NCT05424653
First Posted
June 15, 2022
Last Updated
June 15, 2022
Sponsor
Chengdu Silara Meditech Inc.
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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