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Recruiting NCT04414865

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

— Observational Aortic Valve Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VitaFlow™ Transcatheter Aortic Valve System.
Who it may be relevant to
Registry conditions: Aortic Valve Stenosis. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective, Multi-center, Post-market Registry Study Evaluating Safety and Effectiveness of the Microport™CardioFlow VitaFlow™Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis

Overview

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.

Detailed 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.

Interventions

  • Device VitaFlow™ Transcatheter Aortic Valve System
    VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set

Primary outcome measures

  • Rate of all-cause mortality at 12 months post implantation [Time frame: 12 months post implantation]
Secondary outcome measures (9)
  • Valve function-mean transvalvular gradient [Time frame: at discharge, 30 days, 1 year and annually up to 5 years post implantation]
  • Valve function-effective orifice area [Time frame: at discharge, 30 days, 1 year and annually up to 5 years post implantation]
  • Valve function-degree of prosthetic valve regurgitation [Time frame: at discharge, 30 days, 1 year and annually up to 5 years post implantation]
  • Rate of safety events according to VARC2 [Time frame: at immediate, 30 days, 1 year and annually up to 5 years post implantation]
  • Rate of other TAVI-related complications [Time frame: at immediate, 30 days, 1 year and annually up to 5 years post implantation]
  • Rate of device success [Time frame: at immediate post implantation]
  • Rate of balloon pre-dilatation success [Time frame: at immediate post implantation]
  • Rate of balloon post-dilatation success [Time frame: at immediate post implantation]
  • Rate of procedure success [Time frame: at immediate post implantation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • Ruijing Hospital，Jiaotong University School of Medicine — Shanghai
  • Zhongshan Hospital — Shanghai

Identifiers

NCT: NCT04414865 · LAUNCH-2020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗