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OpenTrials
Completed

NCT Number: NCT03588247

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing transfemoral transcatheter aortic valve procedures

Exclusion criteria

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

Treatment and study plan

Transcatheter aortic valve implantation

Procedure

Patients with severe aortic valve stenosis undergo transcatheter aortic valve implantation

Primary outcomes

  1. Mortality

    Time frame: 30 days

    Death during the first month after TAVI

  2. Stroke

    Time frame: 30 days

    Stroke during the first month after TAVI

Secondary outcomes

  1. Pacemaker implantation

    Time frame: 30 days

    Pacemaker during the first month after TAVI

  2. Bleeding

    Time frame: 30 days

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

  3. New onset atrial fibrillation

    Time frame: 30 days

    New onset atrial fibrillation during the first month after TAVI

  4. Myocardial infarction

    Time frame: 30 days

    Myocardial infarction during the first month after TAVI

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: CENTER

Important dates

Study start
2017
Primary completion
2018
Study completion
2023
First posted
Jul 17, 2018
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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