NCT04414878

VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial

A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd. · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	VitaFlow™ II Transcatheter Aortic Valve System	VitaFlow™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire

Timeline

• Start date: 2018-01-31
• Primary completion: 2022-01-31
• Completion: 2027-01-31
• First posted: 2020-06-04
• Last updated: 2020-06-04

Locations

4 sites across 1 country: China