Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
Primary Purpose
Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MicroPort's Transcatheter Aortic Valve and Delivery System
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Disease
Eligibility Criteria
Inclusion Criteria:
- 18 years or older, male or non pregnant women;
- Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥ 40 mmHg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of < 1.0 cm2 (or AVA index < 0.6 cm2/m2)
- Symptomatic due to aortic valve stenosis as demonstrated by NYHA (New York Heart Association) Functional Class ≥ II
- Expectation of life>12 months
- Calcific aortic stenosis, which is suitable for transcatheter aortic valve implantation anatomically
- is evaluated by at least two cardiovascular physicians, and they agreed that medical factors precluding operation suitable for surgery (the probability of death or serious, irreversible morbidity exceeded 50%)
- The subject agreed to comply follow-up evaluation
Exclusion Criteria:
- Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
- aortic valve is a congenital unicuspid valve, or is non-calcified.
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days
- Implanted any heart valve prosthesis, prosthetic valve ring, severe(>3+)mitral valve insufficiency
- Blood dyscrasia such as leukopenia (WBC < 3×109/L), acute anemia (Hgb < 90 g/L), thrombocytopenia (PLT < 50×109/L), bleeding diathesis, or history of coagulopathy.
- Untreated clinically significant coronary artery disease requiring revascularization
- Hemodynamic instability requiring mechanical cardiac assist or mechanical hemodynamic support devices
- Need for emergency surgery for any reason
- Hypertrophic cardiomyopathy with or without obstruction
- Severe ventricular dysfunction with LVEF (Left ventricular ejection fraction) < 20%
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months
- A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.
- Native aortic annulus size < 17 mm or> 29 mm.
- Patient refuses aortic valve replacement surgery.
- Cerebrovascular Accident (CVA) within 6 months, including TIA (transient ischemic attack).
- Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis.
- Life expectancy < 12 months
- Significant abdominal or thoracic aorta disease, including aneurysm, marked tortuosity (hyperacute bend), aortic arch atheroma, narrowing of the abdominal aorta (especially with calcification and surface irregularities), or severe "unfolding" and tortuosity of the thoracic aorta
- Iliofemoral vessel characteristics that would preclude safe placement of 16F to 19F introducer sheath such as severe obstructive calcification, severe tortuosity
- Active bacterial endocarditis or other active infections.
- Bulky calcified aortic valve leaflets in close proximity to coronary ostia
- severe incapacitating dementia.
- Currently participating in an investigational drug or another device study that has not reached its primary endpoint.
- Researchers identify that the patients with poor compliance who cannot be completed in accordance.
Sites / Locations
- Shanghai Zhongshan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MicroPort's Transcatheter Aortic Valve and Delivery System
Arm Description
single arm with intervention that percutaneous implantation of the MicroPort's Transcatheter Aortic Valve and Delivery System
Outcomes
Primary Outcome Measures
All cause mortality or major stroke at 12 months.
Secondary Outcome Measures
MACCE(major adverse cardiovascular and cerebrovascular events)
MACCE is defined as a composite of:
Myocardial infarction (MI)
Hemorrhage
renal failure
vascular complications
block
ventricular arrhythmias
Device success
Device success is defined as
The device successfully enter the vascular approach, transport and release
The valve is placed in the correct anatomical position
The valve achieve the expected effect (mean aortic pressure < 20mmHg or peak velocity < 3m/s, with no severe aortic regurgitation or paravalvular leakage)
Valve performance
Valve performance means:
Transvalvular mean gradient
Effective orifice area
Degree of aortic valve regurgitation (transvalvular and paravalvular)
The improvement of heart function
Full Information
NCT ID
NCT02221921
First Posted
August 14, 2014
Last Updated
August 20, 2014
Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02221921
Brief Title
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
Official Title
Clinical Evaluation of the Safety and Performance of the MicroPort's Transcatheter Aortic Valve and Delivery System for Treatment of Severe Aortic Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for Surgical Valve Replacement.
Detailed Description
Evaluate the performance, safety and clinical benefit of MicroPort's aortic valve prosthesis and delivery system in intervention by peripheral artery.
The study Continuous observe 12 months of safety and efficacy. Approximately 89 patients are recruited in the study with native aortic valve stenosis which are considered unsuitable for Surgical Valve Replacement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MicroPort's Transcatheter Aortic Valve and Delivery System
Arm Type
Experimental
Arm Description
single arm with intervention that percutaneous implantation of the MicroPort's Transcatheter Aortic Valve and Delivery System
Intervention Type
Device
Intervention Name(s)
MicroPort's Transcatheter Aortic Valve and Delivery System
Primary Outcome Measure Information:
Title
All cause mortality or major stroke at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
MACCE(major adverse cardiovascular and cerebrovascular events)
Description
MACCE is defined as a composite of:
Myocardial infarction (MI)
Hemorrhage
renal failure
vascular complications
block
ventricular arrhythmias
Time Frame
30 days, 3, 6 and 12 months
Title
Device success
Description
Device success is defined as
The device successfully enter the vascular approach, transport and release
The valve is placed in the correct anatomical position
The valve achieve the expected effect (mean aortic pressure < 20mmHg or peak velocity < 3m/s, with no severe aortic regurgitation or paravalvular leakage)
Time Frame
7 days post-operation
Title
Valve performance
Description
Valve performance means:
Transvalvular mean gradient
Effective orifice area
Degree of aortic valve regurgitation (transvalvular and paravalvular)
Time Frame
30 days, 3, 6 and 12 months
Title
The improvement of heart function
Time Frame
30 days, 3, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older, male or non pregnant women;
Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient ≥ 40 mmHg, or jet velocity ≥ 4.0 m/s, or an aortic valve area (AVA) of < 1.0 cm2 (or AVA index < 0.6 cm2/m2)
Symptomatic due to aortic valve stenosis as demonstrated by NYHA (New York Heart Association) Functional Class ≥ II
Expectation of life>12 months
Calcific aortic stenosis, which is suitable for transcatheter aortic valve implantation anatomically
is evaluated by at least two cardiovascular physicians, and they agreed that medical factors precluding operation suitable for surgery (the probability of death or serious, irreversible morbidity exceeded 50%)
The subject agreed to comply follow-up evaluation
Exclusion Criteria:
Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment
aortic valve is a congenital unicuspid valve, or is non-calcified.
Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days
Implanted any heart valve prosthesis, prosthetic valve ring, severe(>3+)mitral valve insufficiency
Blood dyscrasia such as leukopenia (WBC < 3×109/L), acute anemia (Hgb < 90 g/L), thrombocytopenia (PLT < 50×109/L), bleeding diathesis, or history of coagulopathy.
Untreated clinically significant coronary artery disease requiring revascularization
Hemodynamic instability requiring mechanical cardiac assist or mechanical hemodynamic support devices
Need for emergency surgery for any reason
Hypertrophic cardiomyopathy with or without obstruction
Severe ventricular dysfunction with LVEF (Left ventricular ejection fraction) < 20%
Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months
A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, Nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated.
Native aortic annulus size < 17 mm or> 29 mm.
Patient refuses aortic valve replacement surgery.
Cerebrovascular Accident (CVA) within 6 months, including TIA (transient ischemic attack).
Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis.
Life expectancy < 12 months
Significant abdominal or thoracic aorta disease, including aneurysm, marked tortuosity (hyperacute bend), aortic arch atheroma, narrowing of the abdominal aorta (especially with calcification and surface irregularities), or severe "unfolding" and tortuosity of the thoracic aorta
Iliofemoral vessel characteristics that would preclude safe placement of 16F to 19F introducer sheath such as severe obstructive calcification, severe tortuosity
Active bacterial endocarditis or other active infections.
Bulky calcified aortic valve leaflets in close proximity to coronary ostia
severe incapacitating dementia.
Currently participating in an investigational drug or another device study that has not reached its primary endpoint.
Researchers identify that the patients with poor compliance who cannot be completed in accordance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Liu, Medical Doctor
Phone
+86 13911002920
Email
davidliu@coremed.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JunBo Ge, Medical Doctor, Professor
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
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Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
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