POLESTAR Trial - An International Multi-center Early Discharge TAVI Program
- Conditions
- Aortic Valve Stenosis
- Registration Number
- NCT03910751
- Lead Sponsor
- Erasmus Medical Center
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 252
- Eligible for ACURATE Neo valve implantation
- Patient agrees to follow-up duration
- Patient is able to understand and sign written informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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
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
- Secondary Outcome Measures
Name Time Method Stroke 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
Major vascular complication 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
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
Valve related dysfunction requiring repeat procedure 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
Patient reported Quality of Life 30 days and 1 year As measured by the KCCQ quality of life questionnaire
Rehospitalization for valve-related symptoms or worsening congestive heart failure 30 days and 1 year As defined by the most recent VARC document
Categorical cost analysis 30 days Derived from length of stay on Intensive care unit and general ward
All-cause rehospitalization 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
Trial Locations
- Locations (15)
ASZ Aalst
🇧🇪Aalst, Belgium
Vancouver General Hospital
🇨🇦Vancouver, Canada
University Hospital Sussex NHS Foundation Trust
🇬🇧Brighton, United Kingdom
Utrecht University Medical Center
🇳🇱Utrecht, Netherlands
AZ Maria Middelares
🇧🇪Gent, Belgium
AZ Sint-Jan Brugge
🇧🇪Brugge, Belgium
UZ Brussel
🇧🇪Brussel, Belgium
Royal Columbian Hospital
🇨🇦New Westminster, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Canada
Erasmus University Medical Center
🇳🇱Rotterdam, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
St. Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, United Kingdom