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The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis

Aortic Valve Disease Clinical Trial

Official title:
A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients Who Have Severe, Calcific, Bicuspid, Aortic Stenosis Requiring Aortic Valve Replacement

Clinical Trial Summary

Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk. However, patients with congenital bicuspid valve have been excluded in those trials. The purpose of this trial is to determine the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve stenosis.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03163329
Study type Interventional
Source China National Center for Cardiovascular Diseases
Contact Yong-jian Wu, M.D, Ph.D
Phone 0086-10-88396780
Email fuwaihospital@hotmail.com
Status Not yet recruiting
Phase Phase 2
Start date February 1, 2018
Completion date October 31, 2024
View Details
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