VitaFlow Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study

  • STATUS
    Recruiting
  • End date
    Dec 30, 2027
  • participants needed
    100
  • sponsor
    Shanghai MicroPort CardioFlow Medtech Co., Ltd.
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Updated on 19 February 2024
See if I qualify
stenosis
aortic valve replacement
aortic stenosis

Summary

The study objective is to evaluate safety and effectiveness/performance of the Microport CardioFlow VitaFlow Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.

Description

This is a prospective, single-arm, multi-center, observational, post-market registry study. The purpose is to evaluate the safety, performance, and effectiveness of the VitaFlow Transcatheter Aortic Valve System in the real world settings.Patients will be seen at pre and post procedure, discharge, 30 days, 1 year and annually up to 5 years.

Details
Condition Aortic Stenosis, VALVULAR HEART DISEASE
Age 70years - 100years
Treatment VitaFlow™ Transcatheter Aortic Valve System
Clinical Study IdentifierNCT04414865
SponsorShanghai MicroPort CardioFlow Medtech Co., Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age70 years
Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity 4.0m/s, or mean transvalvular gradient 40mmHg(1 mmHg=0.133kPa), or aortic valve area0.8cm (or EOA index0.5cm/m)
The patients considered to be not suitable for surgical aortic valve replacement (SAVR)
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

Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve
Vascular diseases or anatomical condition preventing the device access
Previous implantation of mechanical or bioprosthesis valve in the aortic position
Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements
Ongoing sepsis, including active endocarditis
Estimated Life expectancy< 12 months
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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