VitaFlow II Transcatheter Aortic Valve System Pre-market Trial

  • STATUS
    Recruiting
  • End date
    Jan 31, 2027
  • participants needed
    145
  • sponsor
    Shanghai MicroPort CardioFlow Medtech Co., Ltd.
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Updated on 19 February 2024
See if I qualify
stenosis
aortic valve replacement
transcatheter aortic valve implantation
aortic stenosis

Summary

This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport CardioFlow VitaFlow II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.

Description

This a prospective, multi-center, single-arm, objective performance clinical investigation, aiming to evaluate the safety and effectiveness of Microport CardioFlow VitaFlow II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 145 subjects will be enrolled in 18 clinical centers within China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve implantation.

Details
Condition Aortic Stenosis, VALVULAR HEART DISEASE
Age 70years - 100years
Treatment VitaFlow™ II Transcatheter Aortic Valve System
Clinical Study IdentifierNCT04414878
SponsorShanghai MicroPort CardioFlow Medtech Co., Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age70 years
Symptomatic , severe, aortic valve stenosis : peak velocity 4.0m/s, or mean transvalvular gradient 40mmHg(1 mmHg=0.133kPa), or effective orifice area0.8cm (or EOA index0.5cm/m)
NYHAII class
Estimated life-expectancy>12 months after implantation of the prosthetic valve
Anatomically suitable for the transcatheter aortic valve implantation procedure
The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement

Exclusion Criteria

Acute myocardial infarction (MI) in last 30 days before the treatment
Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve
Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation
Previous implantation of heart valve at any position
Hemodynamic instability requiring mechanical hemodynamic support devices
Need for emergency surgery for any reason
Hypertrophic cardiomyopathy with obstruction
Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%;Severe right ventricular dysfunction
Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months
Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements
Congenital aortic valve stenosis or unicuspid aortic valve
Vascular diseases or anatomical condition preventing the device access
Active endocarditis or other active infections at the time of treatment
Participating in another trial and the primary endpoint is not achieved
Inability to comply with the clinical investigation follow-up or other requirements
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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