AzTrials
AzTrials

Aortic Valve StenosisCENTERNCT03588247

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

An observational study of Aortic Valve Stenosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
transcatheter aortic valve implantation
Type of treatment
Surgery or procedure
How many people
12,000 participants
Where
1 siteNetherlands
Study dates
1 Aug 2017to 1 Jan 2023
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

Study population: patients undergoing transfemoral transcatheter aortic valve procedures

Who may be able to join

  • patients undergoing transfemoral transcatheter aortic valve procedures

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Academic Medical Center

    Amsterdam, 1105AZ

Other trials in Netherlands

About this study

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.

Read the 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.

Being tested
transcatheter aortic valve implantation
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcatheter aortic valve implantationProcedure or surgery

    Patients with severe aortic valve stenosis undergo transcatheter aortic valve implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Death during the first month after TAVI

    Measured: 30 days

  2. Stroke

    Stroke during the first month after TAVI

    Measured: 30 days

Secondary outcomes (4)

  1. Pacemaker implantation

    Pacemaker during the first month after TAVI

    Measured: 30 days

  2. Bleeding

    Major or life-threatening bleeding during the first month after TAVI

    Measured: 30 days

  3. New onset atrial fibrillation

    New onset atrial fibrillation during the first month after TAVI

    Measured: 30 days

  4. Myocardial infarction

    Myocardial infarction during the first month after TAVI

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2018
  2. Study start1 Aug 2017
  3. Primary completion1 Jun 2018
  4. Study completion1 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
12,000 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03588247
Sponsor's protocol ID
CENTER-study
Acronym
CENTER
Status last verified
Apr 2024
First submitted
5 Jul 2018
Last updated
26 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Collaborators are invited to participate in analyses

Publications

  • Hemelrijk KI, van Nieuwkerk AC, Vojacek PJ, Gheorge L, Tchetche D, Brito FS Jr, Barbanti M, Kornowski R, Latib A, D'Onofrio A, Ribichini F, Bowden GY, Dumonteil N, Leite RS, Sartori S, D'Errigo P, Tarantini G, Andreaggi S, Orvin K, Pagnesi M, Asmarats L, Dangas G, Mehran R, Delewi R. Pre-Existing and New-Onset Atrial Fibrillation in Patients Undergoing Transcatheter Aortic Valve Implantation. Catheter Cardiovasc Interv. 2026 Jul;108(1):114-123. doi: 10.1002/ccd.70632. Epub 2026 Apr 21.

    PubMed 42013298

  • 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.

    PubMed 39814498

  • 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.

    PubMed 39190595

  • 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.

    PubMed 38151309

  • 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.

    PubMed 36384656

  • 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.

    PubMed 30871358

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Stenosis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03588247, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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