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

University Hospital Center (CHU)

Status: Completed

Conditions: Coronary Syndrome; Hemodynamic Instability

Treatments: Procedure: Transcatheter heart valve implantation with or withour predilatatation

Study type: Observational

Funder types: Other

Identifiers

NCT05140317

RECHMPL21_0342

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients not living in France

Trial design

236 participants in 2 patient groups

Group 1

Description:

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

Treatment:

Procedure: Transcatheter heart valve implantation with or withour predilatatation

Group 2

Description:

the echographists were blinded regarding the groups of the patients

Treatment:

Procedure: Transcatheter heart valve implantation with or withour predilatatation