NCT03588247 (CENTER) is a clinical trial of transcatheter aortic valve implantation in Aortic Valve Stenosis, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).

Who is sponsoring NCT03588247?

NCT03588247 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).

What drugs are being tested in NCT03588247?

Interventions in NCT03588247: transcatheter aortic valve implantation.

What condition does NCT03588247 study?

NCT03588247 studies Aortic Valve Stenosis.

Is NCT03588247 still recruiting?

NCT03588247 is currently completed. Last updated 26 April 2024.

Last reviewed 2024-04-26 · How we verify

NCT03588247: CENTER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 26 April 2024

What this trial tests

trial testing transcatheter aortic valve implantation in Aortic Valve Stenosis in 12,000 participants. Completed in 1 January 2023.

Timeline

1 August 2017

Primary endpoint
1 June 2018

1 January 2023

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	12,000
Start date	1 August 2017
Primary completion	1 June 2018
Estimated completion	1 January 2023
Sites	1 location across Netherlands

Drugs / interventions tested

transcatheter aortic valve implantation

Conditions studied

Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

Eligibility, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Predictors, Incidence, and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation Complicated by Stroke.
Vlastra W, Jimenez-Quevedo P, Tchétché D, Chandrasekhar J, et al · · 2019 · cited 99× · PMID 30871358 · DOI 10.1161/circinterventions.118.007546
Bleeding in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, Clinical Outcomes, and Predictors.
van Nieuwkerk AC, Aarts HM, Hemelrijk KI, Cantón T, et al · · 2023 · cited 41× · PMID 38151309 · DOI 10.1016/j.jcin.2023.10.011
Impact of body mass index on outcomes in patients undergoing transfemoral transcatheter aortic valve implantation.
van Nieuwkerk AC, Santos RB, Sartori S, Regueiro A, et al · · 2021 · cited 16× · PMID 36003588 · DOI 10.1016/j.xjon.2021.03.012
Balloon-Expandable versus Self-Expandable Valves in Transcatheter Aortic Valve Implantation: Complications and Outcomes from a Large International Patient Cohort.
van Nieuwkerk AC, Santos RB, Andraka L, Tchetche D, et al · · 2021 · cited 15× · PMID 34501454 · DOI 10.3390/jcm10174005
Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled Patient-Level Study.
van Nieuwkerk AC, Aarts HM, Hemelrijk KI, Urbano Carrillo C, et al · · 2024 · cited 13× · PMID 39190595 · DOI 10.1161/jaha.123.032901
Surgical Bailout in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, and Clinical Outcomes.
Aarts HM, van Nieuwkerk AC, Hemelrijk KI, Salgado Fernandez J, et al · · 2025 · cited 10× · PMID 39814498 · DOI 10.1016/j.jcin.2024.09.050
Diabetes mellitus in transfemoral transcatheter aortic valve implantation: a propensity matched analysis.
van Nieuwkerk AC, Santos RB, Mata RB, Tchétché D, et al · · 2022 · cited 9× · PMID 36384656 · DOI 10.1186/s12933-022-01654-x
The TAVI Dilemma: Balloon-Expandable or Self-Expanding Transcatheter Heart Valve-Interpreting Current Evidence for Personalized Valve Selection.
Vlachakis PK, Theofilis P, Kachrimanidis I, Soulaidopoulos S, et al · · 2025 · cited 2× · PMID 40869477 · DOI 10.3390/jcm14165651

Verify or expand the search:

Other trials of transcatheter aortic valve implantation

Trials testing the same drug.

NCT03991754 — Prevention of New Onset AF After TAVI (PAF-TAVI Trial) · Phase 3 · unknown

Other recruiting trials for Aortic Valve Stenosis

Currently open trials in the same condition.

NCT07455292 — Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging · NA · recruiting
NCT07008911 — CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation · NA · recruiting
NCT07145463 — Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aorti · NA · recruiting
NCT07520656 — Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing · recruiting
NCT07267117 — Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease · recruiting

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

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03588247 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Last refreshed: 26 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03588247.

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