ClinicalTrials.gg
CompletedNCT03699345Updated Nov 4, 2024

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

An observational study in Aortic Valve Stenosis, sponsored by Edwards Lifesciences. Completed at 11 sites in 6 countries. Per ClinicalTrials.gov, last updated 2024-11-04.

Sponsored by Edwards Lifesciences · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
87
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Aortic Valve Stenosis

Keywords

  • CENTERA
  • THV
  • Transcatheter Heart Valve
03

In context

Aortic Valve Stenosis

1,006 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.

This study's enrollment of 87 is below the median of 200 across 431 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Edwards Lifesciences is the lead sponsor of 128 studies on the registry; 18 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 33 (94%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
87 participants (actual)
Patient registry
No

Groups and cohorts

  • Edwards CENTERA THV

    Device: Transcatheter Aortic Valve Replacement (TAVR)

Interventions

  • DeviceTranscatheter Aortic Valve Replacement (TAVR)

    TAVR with the Edwards CENTERA THV System and accessories

06

What researchers measure

Primary outcomes

  1. All-Cause Mortality

    All-cause mortality at 30 days

    Time frame: 30 days

07

Study locations

11 sites
  • Aarhus University Hospital, Skejby
    Aarhus, 8200, Denmark
  • Clinique Pasteur Toulouse
    Toulouse, 31076, France
  • Johannes Gutenberg Universitaet Mainz
    Mainz, 55131, Germany
  • Deutsches Herzzentrum Muenchen (DHM)
    München, 80636, Germany
  • Universitair Medisch Centrum Utrecht
    Utrecht, 3584 CX, Netherlands
  • Vall d'Hebron University Hospital - Barcelona
    Barcelona, 08035, Spain
  • Hospital Universitario Central de Asturias
    Oviedo, 33011, Spain
  • Brighton and Sussex University Hospital
    Brighton, East Sussex BN2 5BE, United Kingdom
  • Royal Victoria Hospital Belfast
    Belfast, BT12 6BA, United Kingdom
  • Queen Elisabeth Hospital Birmingham
    Birmingham, B15 2TH, United Kingdom
  • Royal Infirmary of Edinburgh
    Edinburgh, EH16 4SA, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03699345
Responsible party
Sponsor
First posted
Oct 9, 2018
Start date
Jan 7, 2019
Primary completion
Aug 14, 2019
Completion
Aug 20, 2024
Last update
Nov 4, 2024

Study contacts

Prof. Hermann Reichenspurner
principal investigator · UKE Hamburg-Eppendorf - University Heart Center
Prof.Dr. Stephan Windecker
principal investigator · Inselspital, Klinik für Kardiologie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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