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Completed

NCT Number: NCT01808274

Safety and Performance Study of the Edwards CENTERA 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 patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

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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

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herzzentrum Universitaet Bonn, Bonn, Germany

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About this study

This is a non-randomized, prospective, multi-center safety and device success study. 34 patients have been enrolled at 4 participating investigational centers in Europe. 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

  • High surgical risk: STS Score ≥ 8,EuroSCORE ≥ 15.
  • NYHA ≥ II.
  • Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
  • 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

    NAP

Secondary outcomes

  1. device success

    Time frame: 30 days

    Device success is defined as a composite of the following events:

    Factor 1: Absence of procedural mortality Factor 2: Correct positioning of a single prosthetic valve into the proper anatomical location Factor 3: Intended performance of the prosthetic heart valve (per the 30-day core lab echo assessment).

    It is measured in % (favorable measures/total measures).

  2. device success

    Time frame: 1 year

    Device success is defined as a composite of the following events:

    Factor 1: Absence of procedural mortality Factor 2: Correct positioning of a single prosthetic valve into the proper anatomical location Factor 3: Intended performance of the prosthetic heart valve (per the 30-day core lab echo assessment).

    It is measured in % (favorable measures/total measures).

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Collaborators

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

Registry information

Acronym: CENTERA-1

Important dates

Study start
2013
Primary completion
2013
Study completion
2018
First posted
Mar 11, 2013
Registry last updated
Nov 20, 2018

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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