NCT04517955

TAVI in Intermediate Risk Septuagenarians With Risk Factors Not Captured by the Traditional Surgical Risk Scores

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: University of Athens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Transcatheter Aortic Valve Replacement

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Implantation (TAVI)	Transcatheter Aortic Valve Implantation with Evolut R or Evolut Pro

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-09-01
• Completion: 2025-03-30
• First posted: 2020-08-19
• Last updated: 2020-08-19

Locations

5 sites across 1 country: Greece