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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis | Device | Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Cardiac
Pulmonary
Kidney function
Frailty
TAVI strategy
Follow up
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250 patients with severe AS and selected for TF-TAVI with the ACURATE Neo valve and eligible for early discharge within 48 hours post TAVI
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Van Mieghem, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASZ Aalst | Aalst | Belgium | ||||
| AZ Sint-Jan Brugge |
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| 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 |
| Bruges |
| Belgium |
| UZ Brussel | Brussels | Belgium |
| 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 |
| Erasmus University Medical Center | Rotterdam | 3015 GD | Netherlands |
| Utrecht University Medical Center | Utrecht | Netherlands |
| University Hospital Sussex NHS Foundation Trust | Brighton | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom |
| University Hospitals of Leicester NHS Trust | Leicester | United Kingdom |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
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