Clinical trial NCT03588247: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 12000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing transfemoral transcatheter aortic valve procedures

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.

Eligibility criteria: Inclusion Criteria:

* patients undergoing transfemoral transcatheter aortic valve procedures

Exclusion Criteria:

* valve-in-valve procedures, other acces routes than transfemoral

Primary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
Secondary outcomes:
measure: Pacemaker implantation
timeFrame: 30 days
measure: Bleeding
timeFrame: 30 days
measure: New onset atrial fibrillation
timeFrame: 30 days
measure: Myocardial infarction
timeFrame: 30 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jan Piek, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Nieuwkerk AC, Santos RB, Mata RB, Tchetche D, de Brito FS Jr, Barbanti M, Kornowski R, Latib A, D'Onofrio A, Ribichini F, Baan J, Oteo-Dominguez J, Dumonteil N, Abizaid A, Sartori S, D'Errigo P, Tarantini G, Lunardi M, Orvin K, Pagnesi M, Ghattas A, Amat-Santos I, Dangas G, Mehran R, Delewi R. Diabetes mellitus in transfemoral transcatheter aortic valve implantation: a propensity matched analysis. Cardiovasc Diabetol. 2022 Nov 16;21(1):246. doi: 10.1186/s12933-022-01654-x.
citation: Vlastra W, Jimenez-Quevedo P, Tchetche D, Chandrasekhar J, de Brito FS Jr, Barbanti M, Kornowski R, Latib A, D'Onofrio A, Ribichini F, Baan J, Tijssen JGP, De la Torre Hernandez JM, Dumonteil N, Sarmento-Leite R, Sartori S, Rosato S, Tarantini G, Lunardi M, Orvin K, Pagnesi M, Hernandez-Antolin R, Modine T, Dangas G, Mehran R, Piek JJ, Delewi R. Predictors, Incidence, and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation Complicated by Stroke. Circ Cardiovasc Interv. 2019 Mar;12(3):e007546. doi: 10.1161/CIRCINTERVENTIONS.118.007546.