Trial Closed

Summary

The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices. The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.

Description

This is a post market, multi-center (sites in US/CAN/EMEA/ANZ), prospective, non-randomized study.

The addendum is a post market, multi-center (sites in US only), prospective, non-randomized study.

Principal Investigator

Elie Gharib

Study Coordinator

Anthony Bell

Research Contact

Anthony Bell - anthony.bell@vandaliahealth.org

Departments

Cardiology

Sex

All

Age

No age criteria

NCT Number

NCT04091048

IRB Number

20-658

Phase(s)

Not applicable

Link

None