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Completed

NCT Number: NCT03699345

CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System

This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

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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

Aarhus University Hospital, Skejby, Aarhus, Denmark

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About this study

A prospective, international, single arm, multi-center post market clinical follow-up study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Severe native valve calcific aortic stenosis
  • Judged by the Heart Team to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator).

Exclusion criteria

  • Known hypersensitivity to Nitinol (nickel or titanium)
  • Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
  • Inability to tolerate anticoagulation/antiplatelet therapy

Treatment and study plan

Transcatheter Aortic Valve Replacement (TAVR)

Device

TAVR with the Edwards CENTERA THV System and accessories

Primary outcomes

  1. All-Cause Mortality

    Time frame: 30 days

    All-cause mortality at 30 days

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve System

Important dates

Study start
2019
Primary completion
2019
Study completion
2024
First posted
Oct 9, 2018
Registry last updated
Nov 4, 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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