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

Last updated: January 15, 2024
Sponsor: University Hospital, Montpellier
Overall Status: Completed

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Treatment

Transcatheter heart valve implantation with or withour predilatatation

Clinical Study ID

NCT05140317
RECHMPL21_0342
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Older than 18 years old.
  • patients included in the DIRECTAVI trial

Exclusion

Exclusion criteria:

  • Patients not living in France

Study Design

Total Participants: 236
Treatment Group(s): 1
Primary Treatment: Transcatheter heart valve implantation with or withour predilatatation
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
August 01, 2023

Study Description

All patients (n=236) included in the DIRECTAVI randomized trial conducted between May 2016 to May 2018 will be prospectively assessed for up to 5 years follow-up . The DIRECTAVI prospective, randomized, single-center, open-label trial, demonstrated the non-inferiority of a "direct TAVR" strategy using the third-generation balloon-expandable Edwards SAPIEN 3 device (Edwards Lifesciences, Irvine, CA, USA)

A systematic echographic follow-up will be performed in all patients enrolled in the DIRECTAVI trial at the longest follow -up obtained after TAVR between 2021 and 2022. Clinical follow-up will be obtained with a brief patient clinical questionnaire or by phone by patients' cardiologist.

Serial Echographic follow-up will be obtained by patients' cardiologist except for the latest follow-up echocardiography (primary end point) performed in the reference center at Montpellier University hospital by two experienced cardiologists specialized in valvular echography to avoid inter operator variability.

Connect with a study center

  • Uhmontpellier

    Montpellier, 34295
    France

    Site Not Available

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