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Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

Bicuspid Aortic Valve Clinical Trial

Official title:
Transcatheter Aortic Valve Replacement (TAVR) With Medtronic TAVR System in Patients With Severe Bicuspid Aortic Valve Stenosis and at Low Predicted Risk of Mortality With Surgical Aortic Valve Replacement (SAVR)

Clinical Trial Summary

The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR

Clinical Trial Description

Multi-center, prospective, single arm All subjects will be treated with a Medtronic TAVR system. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 1 year, and annually through 10 years ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03635424
Study type Interventional
Source Medtronic Cardiovascular
Contact
Status Active, not recruiting
Phase N/A
Start date October 30, 2018
Completion date December 2030
View Details
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