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

M

MicroPort

Status

Enrolling

Conditions

Aortic Valve Stenosis

Treatments

Device: VitaFlow™ Transcatheter Aortic Valve System

Study type

Observational

Funder types

Industry

Identifiers

NCT04414865
LAUNCH-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age≥70 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 area<0.8cm² (or EOA index<0.5cm²/m²);
  • 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.

Trial design

100 participants in 1 patient group

single arm, treatment group
Description:
Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System
Treatment:
Device: VitaFlow™ Transcatheter Aortic Valve System

Trial contacts and locations

2

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Central trial contact

Jie Bi; Zhujun Cai, PhD

Data sourced from clinicaltrials.gov

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