Aortic Valve Stenosis
Conditions
Keywords
TAVI, TAVR, Early discharge, ACURATE Neo
Brief summary
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
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.
Interventions
DEVICETranscatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis
Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis
Sponsors
Boston Scientific Corporation
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary safety endpoint | 30 days | 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 |
| Primary efficacy endpoint at 30 days | 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 |
| Primary efficacy endpoint at 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury | 30 days and 1 year | As defined by the most recent VARC document |
| Coronary artery obstruction requiring intervention | 30 days and 1 year | As defined by the most recent VARC document |
| Major vascular complication | 30 days and 1 year | As defined by the most recent VARC document |
| Valve related dysfunction requiring repeat procedure | 30 days and 1 year | As defined by the most recent VARC document |
| All-cause rehospitalization | 30 days and 1 year | As defined by the most recent VARC document |
| All-cause mortality | 30 days and 1 year | As defined by the most recent VARC document |
| New permanent pacemaker implantation | 30 days and 1 year | As defined by the most recent VARC document |
| Myocardial infarction | 30 days and 1 year | As defined by the most recent VARC document |
| NYHA heart failure class III or IV | 30 days and 1 year | As defined by the most recent VARC document |
| Patient reported Quality of Life | 30 days and 1 year | As measured by the EQ5D-5L quality of life questionnaire |
| Categorical cost analysis | 30 days | Derived from length of stay on Intensive care unit and general ward |
| Rehospitalization for valve-related symptoms or worsening congestive heart failure | 30 days and 1 year | As defined by the most recent VARC document |
| Stroke | 30 days and 1 year | As defined by the most recent VARC document |
| Life threatening bleeding | 30 days and 1 year | As defined by the most recent VARC document |
Countries
Belgium, Canada, Netherlands, United Kingdom
Outcome results
None listed