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

NCT03588247 | Completed

• 1 other identifier: CENTER-study
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• Mortality

  Death during the first month after TAVI

  30 days

• Stroke

  Stroke during the first month after TAVI

  30 days

Secondary Outcomes (4)

• Pacemaker implantation

  30 days

• Bleeding

  30 days

• New onset atrial fibrillation

  30 days

• Myocardial infarction

  30 days

Interventions

transcatheter aortic valve implantation PROCEDURE

Patients with severe aortic valve stenosis undergo transcatheter aortic valve implantation

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing transfemoral transcatheter aortic valve procedures

You may qualify if:

• patients undergoing transfemoral transcatheter aortic valve procedures

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

Related Publications (5)

• Aarts HM, van Nieuwkerk AC, Hemelrijk KI, Salgado Fernandez J, Tchetche D, de Brito FS Jr, Barbanti M, Kornowski R, Latib A, D'Onofrio A, Ribichini F, Ferrer MC, Dumonteil N, Abizaid A, Sartori S, D'Errigo P, Tarantini G, Del Sole AP, Orvin K, Pagnesi M, Pinar E, Dangas G, Mehran R, Voskuil M, Delewi R. Surgical Bailout in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, and Clinical Outcomes. JACC Cardiovasc Interv. 2025 Jan 13;18(1):89-99. doi: 10.1016/j.jcin.2024.09.050.

  PMID: 39814498 DERIVED

• 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.

  PMID: 39190595 DERIVED

• 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.

  PMID: 38151309 DERIVED

• 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.

  PMID: 36384656 DERIVED

• 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.

  PMID: 30871358 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Jan Piek, Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: July 17, 2018
• Study Start: August 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: January 1, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

NL (1)