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Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221921
Recruitment Status : Not yet recruiting
First Posted : August 21, 2014
Last Update Posted : August 21, 2014
Sponsor:
Information provided by (Responsible Party):
Shanghai MicroPort Medical (Group) Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Disease Aortic Valve Stenosis Aortic Valve Calcification Device: MicroPort's Transcatheter Aortic Valve and Delivery System Not Applicable

Detailed Description:
  1. Evaluate the performance, safety and clinical benefit of MicroPort's aortic valve prosthesis and delivery system in intervention by peripheral artery.
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MicroPort's Transcatheter Aortic Valve and Delivery System
single arm with intervention that percutaneous implantation of the MicroPort's Transcatheter Aortic Valve and Delivery System
Device: MicroPort's Transcatheter Aortic Valve and Delivery System



Primary Outcome Measures :
  1. All cause mortality or major stroke at 12 months. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. MACCE(major adverse cardiovascular and cerebrovascular events) [ Time Frame: 30 days, 3, 6 and 12 months ]

    MACCE is defined as a composite of:

    • Myocardial infarction (MI)
    • Hemorrhage
    • renal failure
    • vascular complications
    • block
    • ventricular arrhythmias

  2. Device success [ Time Frame: 7 days post-operation ]

    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)

  3. Valve performance [ Time Frame: 30 days, 3, 6 and 12 months ]

    Valve performance means:

    • Transvalvular mean gradient
    • Effective orifice area
    • Degree of aortic valve regurgitation (transvalvular and paravalvular)

  4. The improvement of heart function [ Time Frame: 30 days, 3, 6 and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221921


Contacts
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Contact: David Liu, Medical Doctor +86 13911002920 davidliu@coremed.com.cn

Locations
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China
Shanghai Zhongshan Hospital
Shanghai, China, 200032
Sponsors and Collaborators
Shanghai MicroPort Medical (Group) Co., Ltd.
Investigators
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Principal Investigator: JunBo Ge, Medical Doctor, Professor Shanghai Zhongshan Hospital
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Responsible Party: Shanghai MicroPort Medical (Group) Co., Ltd.
ClinicalTrials.gov Identifier: NCT02221921    
Other Study ID Numbers: U0000SYV
MicroPort Medical ( Registry Identifier: MicroPort Medical )
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction