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

Completed

• Conditions: Coronary Syndrome; Hemodynamic Instability
• Interventions: Procedure: Transcatheter heart valve implantation with or withour predilatatation

• Registration Number: NCT05140317
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-15
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Transcatheter heart valve implantation with or withour predilatatation	the echographists were blinded regarding the groups of the patients
Group 1	Transcatheter heart valve implantation with or withour predilatatation	The direct stargegy group included patients with implanation of the THV without predilatation The reference group included patients with direct implanation of tne THV withour predilaation

Primary Outcome Measures

Name	Time	Method
the incidence of patients without correct hemodynamic performance	up to 5 years	the incidence of patients without correct hemodynamic performance according to the implantation strategy group (direct implantation vs ballon predilatation) at the latest follow-up available (up to 5 years)
the incidence of patients without THV dysfunction	up to 5 years	the incidence of patients without THV dysfunction according to the implantation strategy group (direct implantation vs ballon predilatation) at the latest follow-up available (up to 5 years)

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France