PRospective Evaluation Complementing Investigation With Acurate Neo Device

Study Overview
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Brief Summary
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The study collects real-world data of patients who were treated with the Acurate Neo TAVI System and evaluates early and midterm clinical outcomes.

Detailed Description
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The study collects real-world data of patients who were treated with the Acurate Neo TAVI System and evaluates early and midterm clinical outcomes.

Official Title
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PRospective Evaluation Complementing Investigation With Acurate Neo Device

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Device: Transcatheter Aortic Valve Implantation (TAVI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years. Severe aortic stenosis with indication of implantation of aortic valve prosthesis in which an Acurate Neo device is implanted according to the indications for use. Has signed the Patient Informed Consent Form. Exclusion Criteria: Severe aortic stenosis without indication of implantation of aortic valve prosthesis in which an Acurate Neo device is implanted according to the indications for use.

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 |
| --- | --- |
| Treatment<br>Transcatheter Aortic Valve Implantation (TAVI) | Device: Transcatheter Aortic Valve Implantation (TAVI)<br>* Implantation of the Acurate Neo Transcatheter Heart Valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success of implantation | Proportion of patients with device success of implantation defined as: absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND no prosthesis - patient mismatch AND mean aortic valve gradient <20 mmHg, AND no moderate or severe prosthetic valve regurgitation | 7 days | 
| Cardiovascular death | Cumulative incidence of a combination of all cause Cardiovascular death | 30 days post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of early safety | Proportion of patients with early safety defined by the Valve Academic Research Consortium-2 (VARC-2) as: All-cause mortality All stroke (disabling and non-disabling) Life-threatening bleeding Acute kidney injury-Stage 2 or 3 (including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure | 30 days | 
| Assessment of time-related valve safety | Proportion of patients with structural valve deterioration as defined by: Requiring repeat procedure (transcatheter or surgical heart valve replacement) Valve-related dysfunction defined by mean aortic valve gradient ≥20 mmHg and no moderate or severe prosthetic valve regurgitation Prosthetic valve endocarditis Prosthetic valve thrombosis Thrombo-embolic events (e.g. stroke) VARC bleeding, unless clearly unrelated to valve therapy | 30 days | 
| Assesment of NYHA (New York Heart Association ) classification | Assesment of NYHA classification | 7 days, 30 days, 12 month | 
| Assessment of mean aortic gradient post-implantation | Assessment of mean aortic gradient post-implantation | up to one year | 
| Death during the hospitalization of the patient | Proportion of patients with death during the hospitalization designated by the VARC-2 criteria | date of procedure till date of estimated discharge, assessed up to two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, Valve