Brief Title
Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.
Official Title
Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.
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.
Study Type
Observational [Patient Registry]
Primary Outcome
Mortality
Secondary Outcome
Pacemaker implantation
Condition
Aortic Valve Stenosis
Intervention
transcatheter aortic valve implantation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
12000
Start Date
August 1, 2017
Completion Date
January 1, 2019
Primary Completion Date
June 1, 2018
Eligibility Criteria
Inclusion Criteria: - patients undergoing transfemoral transcatheter aortic valve procedures Exclusion Criteria: - valve-in-valve procedures, other acces routes than transfemoral
Gender
All
Ages
N/A - N/A
Contacts
Jan Piek, Prof., +31205667883, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT03588247
Organization ID
CENTER-study
Responsible Party
Principal Investigator
Study Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Sponsor
Jan Piek, Prof., Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Verification Date
July 2018