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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Syndrome, Hemodynamic Instability

Intervention / Treatment
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* Procedure: Transcatheter heart valve implantation with or withour predilatatation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Older than 18 years old. patients included in the DIRECTAVI trial Exclusion criteria: - Patients not living in France

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>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 | Procedure: Transcatheter heart valve implantation with or withour predilatatation<br>* long term up to 5 years echographic and clinical follow up<br>|
| Group 2<br>the echographists were blinded regarding the groups of the patients | Procedure: Transcatheter heart valve implantation with or withour predilatatation<br>* long term up to 5 years echographic and clinical follow up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of patients without THV dysfunction | 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) | up to 5 years | 
| the incidence of patients without correct hemodynamic performance | 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) | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patients included in the directavi trial, TAVR Hemodynamic performances long term follow up