Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.
- Conditions
- Aortic Valve Stenosis
- Registration Number
- NCT03588247
- Brief Summary
The aim of this collaborative analysis is to evaluate stroke rates and mortality in patients undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES valve. In the absence of large randomized controlled trials, we will conduct a large collaborative patient-pooled meta-analysis on 30-day stroke and mortality in patients undergoing primary transfemoral TAVI with either MCV or ES valve.
- Detailed Description
The main aim of this patient-pooled analyses is to compare stroke rates and mortality in patients undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES valve. However, this collaboration may also be used to compare various outcomes.
Studies were included if they complied with the following requirements: original prospective studies, including patients with aortic valve stenosis treated with transfemoral TAVI of native valves and reporting of 30 day stroke outcomes according to VARC criteria or other specified corresponding criteria . Moreover, to be included studies had to report both the use of self-expandable MCV prosthesis and the balloon-expandable ES valve in more than 50 patients in each arm to ensure experience in use of the valves. Studies were excluded if they only addressed patients undergoing valve-in-valve and re-do procedures or bicuspid valves or included the same study population. Principal Investigators of these studies were approached for collaboration.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12000
- patients undergoing transfemoral transcatheter aortic valve procedures
- valve-in-valve procedures, other acces routes than transfemoral
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stroke 30 days Stroke during the first month after TAVI
Mortality 30 days Death during the first month after TAVI
- Secondary Outcome Measures
Name Time Method New onset atrial fibrillation 30 days New onset atrial fibrillation during the first month after TAVI
Pacemaker implantation 30 days Pacemaker during the first month after TAVI
Myocardial infarction 30 days Myocardial infarction during the first month after TAVI
Bleeding 30 days Major or life-threatening bleeding during the first month after TAVI
Trial Locations
- Locations (1)
Academic Medical Center
🇳🇱Amsterdam, Netherlands