Early neo2 Registry of the Acurate neo2 TAVI Prosthesis

Study Overview
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Brief Summary
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The Early neo2 registry will study up to 500 patients treated with the updated Boston Acurate neo2 TAVI prosthesis at various European hospitals. The data is gathered from routine healthcare and there are no study-mandated additional procedures. The main endpoint is a combined efficiency and safety endpoint after 30 days. Imaging data (echocardiography, computed tomography and aortography) will be analysed centrally by a core lab.

Detailed Description
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Background and rationale The Boston Scientific Acurate neo2 TAVI prosthesis was launched commercially in Europe in September 2020 as a successor to the original Acurate neo prosthesis. Modifications include an added sealing skirt. The original Acurate neo failed to reach non-inferiority to other TAVI prostheses in two randomized trials. There is a need to gather initial safety and efficacy data from this next generation prosthesis, as there is no larger dataset presented after the CE-mark study of the Acurate neo2. Project objectives To gather initial safety and efficacy data in the initial up to 500 consecutive patients treated with the Acurate neo2 in various European sites. Karolinska will be the coordinating center for data collection. Methods Data will be collected in an anonymous form and sent to Karolinska for compilation and statistics. Data collection will continue until 500 patients are reached (April, 2021). Statistics Standard descriptive statistics will be used for the main results. For the comparison to SCOPE data (with the original Acurate neo prosthesis) on postoperative aortic insufficiency, standard statistical methods will used (Fishers exact test for categorical variables, and t-test for continuous measurements such as amount of regurgitation by videodensitometry). Core lab studies The core lab analyses will be performed at CORRIB in Galway (Prof. Serruys et al).

Official Title
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Early neo2 Registry of the Acurate neo2 TAVI Prosthesis

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Boston Scientific Acurate neo2 TAVR device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: that a Acurate neo2 prosthesis has been inserted into the sheath (i.e. a procedure has been started). Exclusion Criteria: None
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

| Intervention/Treatment |
| --- |
|Device: Boston Scientific Acurate neo2 TAVR device|The newest generation of the Acurate neo2 TAVR device, launched in Europe in 2020.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | any of Postoperative aortic insuffiency moderate or higher (in hospital echo, site reported) Postoperative new permanent pacemaker (in hospital) 30 days mortality 30 days stroke Acute Kidney Injury (AKIN grade 3) (in hospital) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Postoperative aortic insufficiency more than mild by transthoracic echo | Core-lab analysis of the postoperative transthoracic echo for aortic insufficiency: percentage of patients with more than mild insufficiency | Within 7 days of procedure | 
| Rate of Postoperative aortic insufficiency more than mild by aortography | Core-lab analysis of the aortogram in the end of the procedure for quantification of aortic insufficiency (videodensitometry): rate of patients with more than mild insuffiency | Same day as procedure | 
| Postoperative aortic valve gradients | Aortic prosthesis mean gradient (mmHg) on postoperative transthoracic echocardiogram | Within 7 days of procedure | 
| Rate of major acute procedural complications | Intraprocedural complications such as valve embolization, need for second valve, anular rupture | Same day as procedure | 
| Procedural contrast use | The average amount of contrast in ml per procedure | Same day as procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVR