VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04414878
Study type	Interventional
Source	Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Contact	Bi Jie
Phone	(86)(21)38954600
Email	jbi@microport.com
Status	Recruiting
Phase	N/A
Start date	January 31, 2018
Completion date	January 31, 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04310046` - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial	N/A
Completed	`NCT03332745` - Mechanism of Decompensation Evaluation - Aortic Stenosis
Recruiting	`NCT06008080` - Post-Market Clinical Follow Up Study With Navitor Valve
Recruiting	`NCT06055751` - Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry
Active, not recruiting	`NCT04815785` - Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis	N/A
Terminated	`NCT02202434` - Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement	N/A
Recruiting	`NCT03029026` - The Role of Occult Cardiac Amyloid in the Elderly With Aortic Stenosis.
Active, not recruiting	`NCT02903420` - A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)	N/A
Completed	`NCT02629328` - CardioCel Tri-leaflet Repair Study	N/A
Completed	`NCT02306226` - Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Completed	`NCT01676727` - ADVANCE Direct Aortic Study
Withdrawn	`NCT01648309` - Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation	N/A
Completed	`NCT01422044` - Risk Prediction in Aortic Stenosis	N/A
Withdrawn	`NCT00774657` - Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography	N/A
Terminated	`NCT00535899` - Speckle Tracking Imaging in Patients With Low Ejection Fraction Aortic Stenosis (SPArKLE-AS)	N/A
Terminated	`NCT05070130` - OpSens PRIME CLASS
Completed	`NCT03314857` - China XT: Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population	N/A
Completed	`NCT04157920` - Impact of Predilatation Between Self-expanding Valves	N/A
Enrolling by invitation	`NCT06212050` - Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Recruiting	`NCT05893082` - Multicenter Feasibility Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR	N/A