Project to Look for Early Discharge in Patients Undergoing TAVI With ACURATE - An International Multi-center Early Discharge TAVI Program
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Erasmus Medical Center
- Enrollment
- 252
- Locations
- 15
- Primary Endpoint
- Primary safety endpoint
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Nicolas van Mieghem
Principal Investigator
Erasmus Medical Center
Eligibility Criteria
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
- •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
- •COPD Gold \> 2
- •Kidney function
- •GFR \< 35ml/min
Outcomes
Primary Outcomes
Primary safety endpoint
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Stroke(30 days and 1 year)
- Major vascular complication(30 days and 1 year)
- Acute kidney injury(30 days and 1 year)
- All-cause mortality(30 days and 1 year)
- Life threatening bleeding(30 days and 1 year)
- Coronary artery obstruction requiring intervention(30 days and 1 year)
- Valve related dysfunction requiring repeat procedure(30 days and 1 year)
- New permanent pacemaker implantation(30 days and 1 year)
- Patient reported Quality of Life(30 days and 1 year)
- Rehospitalization for valve-related symptoms or worsening congestive heart failure(30 days and 1 year)
- Categorical cost analysis(30 days)
- All-cause rehospitalization(30 days and 1 year)
- Myocardial infarction(30 days and 1 year)
- NYHA heart failure class III or IV(30 days and 1 year)