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5 Years Follow up of the SAPIEN 3 Valve From the DIRECTAVI Trial

NCT05140317 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 236

Last updated 2024-01-17

No results posted yet for this study

Summary

A strategy of Transcatheter Aortic Valve Replacement (TAVR) without balloon predilatation has shown to be feasible in routine in observational studies and in two recent randomized trial including the DIRECTAVI trial. Whether the initial implantation strategy may impact the long-term trans catheter heart valve (THV) performances and patient outcomes remains unknown to date. The Investigators therefore aimed to evaluate the 5-years impact of the implantation strategy on THV hemodynamic performances and clinical outcomes in patients included in the DIRECTAVI trial.

Conditions

  • Coronary Syndrome
  • Hemodynamic Instability

Interventions

PROCEDURE

Transcatheter heart valve implantation with or withour predilatatation

long term up to 5 years echographic and clinical follow up

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Florence Leclercq, PU PH · University Hospital, Montpellier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-08-01
Completion
2023-08-01

Countries

  • France

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 NCT05140317 on ClinicalTrials.gov