POLESTAR Trial - An International Multi-center Early Discharge TAVI Program

Study Overview
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Brief Summary
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An international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are eligible for transfemoral TAVI with the Boston Scientific ACURATE Neo Aortic Bioprosthesis transcatheter heart valve.

Detailed Description
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In this International multi-center prospective observational study, 250 patients with severe symptomatic aortic stenosis (AS) and eligibility for transfemoral TAVI with ACURATE Neo Bioprosthesis, will be pre-procedurally selected for participation in an early discharge protocol in which patients are discharged within 48 hours after uncomplicated TAVI.

Official Title
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Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE - An International Multi-center Early Discharge TAVI Program

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for ACURATE Neo valve implantation Patient agrees to follow-up duration Patient is able to understand and sign written informed consent Exclusion Criteria: BMI > 35 Pregnancy Cardiac Moderate to severely impaired left ventricular ejection fraction (LVEF <35%) Mitral regurgitation > moderate Pulmonary hypertension (sPAP > 60mmHg) No complex coronary artery disease Untreated high degree AV-block or RBBB Pulmonary COPD Gold > 2 Kidney function GFR < 35ml/min Frailty Inappropriate social support and/or (familial) care Patient is walking aid dependent TAVI strategy Presence of severe peripheral artery disease Transfemoral approach not possible Follow up Inability to adhere to follow-up

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

| Intervention/Treatment |
| --- |
|Device: Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis|Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary safety endpoint | Composite of all-cause mortality, any stoke, VARC type 2-4 bleeding, acute kidney injury stage 3-4, major vascular, major access related, major cardiac structural complication, moderate or severe aortic regurgitation, new permanent pacemaker implantation and valve-related dysfunction requiring repeat procedure at 30 days | 30 days | 
| Primary efficacy endpoint at 30 days | Composite of all-cause mortality, all stroke, re-hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score <45 or decline from baseline >10 points at 30 days | 30 days | 
| Primary efficacy endpoint at 1 year | Composite of all-cause mortality, all stroke, re-hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score <45 or decline from baseline >10 points at 1 year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | As defined by the most recent VARC document | 30 days and 1 year | 
| Stroke | As defined by the most recent VARC document | 30 days and 1 year | 
| Life threatening bleeding | As defined by the most recent VARC document | 30 days and 1 year | 
| Acute kidney injury | As defined by the most recent VARC document | 30 days and 1 year | 
| Coronary artery obstruction requiring intervention | As defined by the most recent VARC document | 30 days and 1 year | 
| Major vascular complication | As defined by the most recent VARC document | 30 days and 1 year | 
| Valve related dysfunction requiring repeat procedure | As defined by the most recent VARC document | 30 days and 1 year | 
| All-cause rehospitalization | As defined by the most recent VARC document | 30 days and 1 year | 
| Rehospitalization for valve-related symptoms or worsening congestive heart failure | As defined by the most recent VARC document | 30 days and 1 year | 
| New permanent pacemaker implantation | As defined by the most recent VARC document | 30 days and 1 year | 
| Myocardial infarction | As defined by the most recent VARC document | 30 days and 1 year | 
| NYHA heart failure class III or IV | As defined by the most recent VARC document | 30 days and 1 year | 
| Patient reported Quality of Life | As measured by the EQ5D-5L quality of life questionnaire | 30 days and 1 year | 
| Patient reported Quality of Life | As measured by the KCCQ quality of life questionnaire | 30 days and 1 year | 
| Categorical cost analysis | Derived from length of stay on Intensive care unit and general ward | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, TAVR, Early discharge, ACURATE Neo