NCT02221921

Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI

Clinical Evaluation of the Safety and Performance of the MicroPort's Transcatheter Aortic Valve and Delivery System for Treatment of Severe Aortic Stenosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (estimated)
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for Surgical Valve Replacement.

Detailed description

1. Evaluate the performance, safety and clinical benefit of MicroPort's aortic valve prosthesis and delivery system in intervention by peripheral artery. 2. The study Continuous observe 12 months of safety and efficacy. Approximately 89 patients are recruited in the study with native aortic valve stenosis which are considered unsuitable for Surgical Valve Replacement.

Conditions

• Aortic Valve Disease
• Aortic Valve Stenosis
• Aortic Valve Calcification

Interventions

Type	Name	Description
DEVICE	MicroPort's Transcatheter Aortic Valve and Delivery System

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-09-01
• Completion: 2021-09-01
• First posted: 2014-08-21
• Last updated: 2014-08-21

Locations

1 site across 1 country: China