Transcatheter Aortic Valve Replacement Clinical Trial
Official title:
TAVI in Intermediate Risk Septuagenarians With Risk Factors Not Captured by the Traditional Surgical Risk Scores
Single arm, observational trial of Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic Evolut R and Evolut Pro The primary objective of this trial is to evaluate device success of TAVI with the Evolut R and Evolut Pro systems in septuagenarians with risk factors for adverse surgical outcomes not captured by the traditional risk scores and therefore of intermediate surgical risk.
The purpose of this study is to investigate the safety and efficacy of transcatheter aortic
valve implantation (TAVI) in septuagenarians with severe, symptomatic Aortic Stenosis (AS)
and risk factors for adverse surgical outcomes not captured by the traditional risk scores
and therefore of intermediate surgical risk.
The primary objective of this trial is to evaluate device success of TAVI with the Evolut R
and Evolut Pro systems in septuagenarians with risk factors for adverse surgical outcomes not
captured by the traditional risk scores and therefore of intermediate surgical risk.
The secondary objective is to assess early safety (at 30 days) and clinical efficacy (after
30 days) of the TAVI procedure.
Exploratory objective: comparative health economics in septuagenarians with symptomatic
severe aortic stenosis and intermediate surgical risk treated with Transcatheter Aortic Valve
Implantation (TAVI) vs Surgical Aortic Valve Replacement (SAVR) (matched historic cohort)
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