CLINICAL EVIDENCE — REAL WORLD RESULTS TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI)

   Indications, Safety, and Warnings

EXCELLENT RESULTS DEMONSTRATED IN REAL-WORLD SETTINGS

Data indicates the Medtronic TAVI platform clinical performance provides reproducible results and performs well over time.

FORWARD STUDY1

This multicenter, prospective, single-arm, observational post-market study evaluated the safety and performance of the Evolut R system in a routine hospital setting.

  • Study Status/Duration: 12-month outcomes reported/3-year follow-up
  • Sample Size: N = 1040
  • Devices: Evolut R TAV

1 year hemodynamic data
Valve Performance

SEE DATA

30-day procedural outcomes
All Cause Rates

 

ADVANCE Study2

ADVANCE is a multicenter, prospective, single-arm, observational study to evaluate safety and performance of the CoreValve™ system in a routine clinical setting.

Study Status/Duration: 5-year outcomes reported/5-year follow-up
Sample Size: N = 1,015
Devices: CoreValve, TAV

SEE STUDY DATA

Graph showing effective orifice area and mean gradient over 5 years.
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For a summary of all TAVI clinical studies, see Clinical Evidence Compendium

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1

Grube, as presented at EuroPCR 2018

2

Gerckens U, Tamburino C, Bleiziffer S, et al. Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study. Eur Heart J. September 21, 2017;38(36):2729-2738.