NCT04414865

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-04-26
• Primary completion: 2021-12-01
• Completion: 2027-12-30
• First posted: 2020-06-04
• Last updated: 2020-06-04

Locations

2 sites across 1 country: China