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.
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.
Study Type
OBSERVATIONAL
Enrollment
252
Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis
ASZ Aalst
Aalst, Belgium
AZ Sint-Jan Brugge
Bruges, Belgium
UZ Brussel
Brussels, Belgium
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
Time frame: 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
Time frame: 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
Time frame: 1 year
All-cause mortality
As defined by the most recent VARC document
Time frame: 30 days and 1 year
Stroke
As defined by the most recent VARC document
Time frame: 30 days and 1 year
Life threatening bleeding
As defined by the most recent VARC document
Time frame: 30 days and 1 year
Acute kidney injury
As defined by the most recent VARC document
Time frame: 30 days and 1 year
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AZ Maria Middelares
Ghent, Belgium
Royal Columbian Hospital
New Westminster, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada
Vancouver General Hospital
Vancouver, Canada
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
...and 5 more locations
Coronary artery obstruction requiring intervention
As defined by the most recent VARC document
Time frame: 30 days and 1 year
Major vascular complication
As defined by the most recent VARC document
Time frame: 30 days and 1 year
Valve related dysfunction requiring repeat procedure
As defined by the most recent VARC document
Time frame: 30 days and 1 year
All-cause rehospitalization
As defined by the most recent VARC document
Time frame: 30 days and 1 year
Rehospitalization for valve-related symptoms or worsening congestive heart failure
As defined by the most recent VARC document
Time frame: 30 days and 1 year
New permanent pacemaker implantation
As defined by the most recent VARC document
Time frame: 30 days and 1 year
Myocardial infarction
As defined by the most recent VARC document
Time frame: 30 days and 1 year
NYHA heart failure class III or IV
As defined by the most recent VARC document
Time frame: 30 days and 1 year
Patient reported Quality of Life
As measured by the EQ5D-5L quality of life questionnaire
Time frame: 30 days and 1 year
Patient reported Quality of Life
As measured by the KCCQ quality of life questionnaire
Time frame: 30 days and 1 year
Categorical cost analysis
Derived from length of stay on Intensive care unit and general ward
Time frame: 30 days