NCT05140317

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

5 Years Hemodynamic and Clinical Follow-up of the SAPIEN 3 Transcatheter Heart Valve According to the Implantation Strategy: Insight From the Randomized DIRECTAVI Trial

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 236 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Syndrome
• Hemodynamic Instability

Interventions

Type	Name	Description
PROCEDURE	Transcatheter heart valve implantation with or withour predilatatation	long term up to 5 years echographic and clinical follow up

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2021-12-01
• Last updated: 2024-01-17

Locations

1 site across 1 country: France