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

NCT04517955 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2020-08-19

No results posted yet for this study

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.

Conditions

  • Transcatheter Aortic Valve Replacement

Interventions

DEVICE

Transcatheter Aortic Valve Implantation (TAVI)

Transcatheter Aortic Valve Implantation with Evolut R or Evolut Pro

Sponsors & Collaborators

  • University of Athens

    lead OTHER

Principal Investigators

  • Dimitris Tousoulis, Prof · First Department of Cardiology, University of Athens

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-09-01
Completion
2025-03-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04517955 on ClinicalTrials.gov