PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis

Study Overview
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Brief Summary
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Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world. Per year, about 1.8-1.9% of these patients develop aortic valve stenosis which will eventually be treated by TAVI (Transcatheter aortic valve implantation). The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, hereafter referred to as the ACURATE neo2™ and transfemoral delivery system in the context of an observational investigator initiated trial (IIT).

Detailed Description
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There are four leading causes of valvular aortic valve stenosis, namely: calcific aortic stenosis, congenital aortic valve malformations, rheumatic aortic valve stenosis, and endocarditis. Calcific aortic valve stenosis is a chronic progressive disease, and the predominant cause of aortic valve stenosis in the Western world. Multiple mechanisms influencing the progression of aortic valve stenosis have been identified. However, there is still no sufficient drug therapy to stop or reverse the process. If high-grade aortic valve stenosis becomes symptomatic, death rates increase up to 50% in 2 years.Many patients with severe and symptomatic aortic stenosis are successfully treated with surgical aortic valve replacement (SAVR), which can reduce symptoms and improve survival. However, up to one-third of symptomatic patients are considered inoperable due to comorbidities and the high risk of surgery. This treatment gap forced the development of less invasive approaches for patients with aortic stenosis considered inoperable and led to the development of TAVI. Later, TAVI has also been considered in the European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2017 and American Heart Association/American College of Cardiology (AHA/ACC) guidelines for the management of patients with valvular heart disease and intermediate surgical risk and recently, new landmark studies have expanded the use of TAVI into the low surgical risk field. For the establishment of TAVI as the first line treatment option in lower risk patients, further improvement with regard to adverse outcomes associated with TAVI (e.g. vascular complications, rates of paravalvular leak/aortic regurgitation and the need for permanent pacemakers) will be essential. Therefore, large registries are needed to detect rare events and tendencies in a real-world setting. The PROVE study will collect baseline, procedural and follow-up data. In addition, it will serve as an imaging library (angiography, echocardiography and cardiac computed tomography) to evaluate the potential advantages and disadvantages of the ACURATE neo2.

Official Title
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PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Device: Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned transcatheter treatment of severe aortic stenosis with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system. Age ≥ 18 years of age Written informed consent by patient and/or legal representative Exclusion Criteria: Patient is unlikely to be able or willing to follow the investigator's instructions during study participation. Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients) 3. Patients placed in an institution by official or court order

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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>Patients with planned transcatheter treatment of severe aortic stenosis with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system. | Device: Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.<br>* The study will collect data from patients treated with the ACURATE neo2™ and its transfemoral delivery system following standard TAVI practice at each participating center. All patients will be followed to 12 months after the implant procedure. The study is divided into three periods: Screening period: from screening to enrollment if study criteria are met. Implantation procedure: immediately pre-implant to 24 hours post-procedure. Follow-up period: at hospital discharge, at 30 days and at 12 months post-procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to all-cause death | The individual survival time is calculated from the day of procedure up to death of any cause or up to the last last date on which the patient was known to be alive. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality (count) | Numbers by cause and timing period | through study completion, an average of 1 year | 
| Mortality (rate) | Rates, by cause and timing period | through study completion, an average of 1 year | 
| Neurological events (count) | Numbers by type, grading and timing | through study completion, an average of 1 year | 
| Neurological events (rate) | Rates by type, grading and timing | through study completion, an average of 1 year | 
| Myocardial infarction (count) | Numbers by type | through study completion, an average of 1 year | 
| Myocardial infarction (rate) | Rates, by type | through study completion, an average of 1 year | 
| Re-hospitalization (count) | Re-hospitalization yes/no: numbers -> Total number of re-hospitalization per patient, by type | through study completion, an average of 1 year | 
| Re-hospitalization (cumulative incidence) | Re-hospitalization yes/no: rates Cumulative incidence of first re-hospitalization, by type | through study completion, an average of 1 year | 
| Bleeding events (count) | Numbers by type | through study completion, an average of 1 year | 
| Bleeding events (rate) | Rates by type | through study completion, an average of 1 year | 
| Transfusions | Total number per patient, by timing period | through study completion, an average of 1 year | 
| Vascular and access-related complications (count) | Numbers by type and severity | through study completion, an average of 1 year | 
| Vascular and access-related complications (rate) | Rates by type and severity | through study completion, an average of 1 year | 
| Cardiac structural complications (count) | Numbers by severity | through study completion, an average of 1 year | 
| Cardiac structural complications (rate) | Rates by severity | through study completion, an average of 1 year | 
| Other acute procedural and technical valve related complications (count) | Numbers by category and type of clinical presentation | through study completion, an average of 1 year | 
| Other acute procedural and technical valve related complications (rate) | Rates by category and type of clinical presentation | through study completion, an average of 1 year | 
| Conduction disturbances and arrhythmia (count) | Numbers by type, timing and duration | through study completion, an average of 1 year | 
| Conduction disturbances and arrhythmia (rate) | Rates by type, timing and duration | through study completion, an average of 1 year | 
| Acute kidney injury (count) | Numbers by stage | through study completion, an average of 1 year | 
| Acute kidney injury (rate) | Rates by stage | through study completion, an average of 1 year | 
| Bioprosthetic valve dysfunction (count) | Numbers by type | through study completion, an average of 1 year | 
| Bioprosthetic valve dysfunction (rate) | Rates by type | through study completion, an average of 1 year | 
| Clinically significant valve thrombosis (count) | Numbers by timing period | through study completion, an average of 1 year | 
| Clinically significant valve thrombosis (rate) | Rates by timing period | through study completion, an average of 1 year | 
| Patient-reported outcomes and health status | Kansas City Cardiomyopathy Questionnaire (KCCQ) | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter aortic valve implantation (TAVI), ACURATE neo2™ bioprosthetic aortic valve, ACURATE neo2™ transfemoral delivery system