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Completed

NCT Number: NCT02458560

CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Prince Charles Hospital, Brisbane, Queensland, Australia

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About this study

This is a non-randomized, prospective, multi-center safety and device success study. Up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in Europe, Australia and New Zealand. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Heart team (including cardiac surgeon) agrees on eligibility including as-sessment that TAVI is appropriate.
  • High surgical risk: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE I ≤ 40.
  • NYHA ≥ II.
  • Study patient is an adult of legal consent age.
  • Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.

Exclusion criteria

  • Acute myocardial infarction ≤ 30 days before the intended treatment.
  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Aortic valve is a congenital unicuspid or congenital bicuspid valve.
  • Mixed aortic valve disease (with predominant aortic regurgitation).

Treatment and study plan

Edwards CENTERA Self-Expanding Transcatheter Heart Valve

Device

The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR).

Other names: TAVR, TAVI

Primary outcomes

  1. All-cause mortality rate

    Time frame: 30 days post-index procedure

Secondary outcomes

  1. Safety composite of mortality, stroke, major vascular, complication, life-threatening bleeding, acute kidney injury coronary artery obstruction requiring intervention, and THV-related dysfunction requiring repeat procedure.

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Collaborators

  • European Cardiovascular Research Center
  • Medstar Health Research Institute
  • University of British Columbia

Registry information

Official study title

Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

Important dates

Study start
2015
Primary completion
2016
Study completion
2021
First posted
Jun 1, 2015
Registry last updated
Oct 18, 2021

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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