Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.

NCT ID: NCT03588247

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2023-01-01

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.

Conditions

Aortic Valve Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

transcatheter aortic valve implantation

Patients with severe aortic valve stenosis undergo transcatheter aortic valve implantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients undergoing transfemoral transcatheter aortic valve procedures

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Jan J. Piek, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Piek, Prof.

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Locations

Academic Medical Center

Amsterdam, , Netherlands

Countries

Netherlands

References

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Reference Type: DERIVED

PMID: 39814498 (View on PubMed)

van Nieuwkerk AC, Aarts HM, Hemelrijk KI, Urbano Carrillo C, Tchetche D, de Brito FS Jr, Barbanti M, Kornowski R, Latib A, D'Onofrio A, Ribichini F, Garcia-Blas S, Dumonteil N, Abizaid A, Sartori S, D'Errigo P, Tarantini G, Lunardi M, Orvin K, Pagnesi M, Navarro F, Dangas G, Mehran R, Delewi R. Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient-Level Study. J Am Heart Assoc. 2024 Sep 3;13(17):e032901. doi: 10.1161/JAHA.123.032901. Epub 2024 Aug 27.

Reference Type: DERIVED

PMID: 39190595 (View on PubMed)

van Nieuwkerk AC, Aarts HM, Hemelrijk KI, Canton T, Tchetche D, de Brito FS Jr, Barbanti M, Kornowski R, Latib A, D'Onofrio A, Ribichini F, Maneiro Melon N, Dumonteil N, Abizaid A, Sartori S, D'Errigo P, Tarantini G, Fabroni M, Orvin K, Pagnesi M, Vicaino Arellano M, Dangas G, Mehran R, Voskuil M, Delewi R. Bleeding in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, Clinical Outcomes, and Predictors. JACC Cardiovasc Interv. 2023 Dec 25;16(24):2951-2962. doi: 10.1016/j.jcin.2023.10.011.

Reference Type: DERIVED

PMID: 38151309 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36384656 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30871358 (View on PubMed)

Other Identifiers

CENTER-study

Identifier Type: -

Identifier Source: org_study_id