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

October 31, 2024 updated by: Edwards Lifesciences

Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital, Skejby
  • France
      • Toulouse Cedex 3, France, 31076
        • Clinique Pasteur Toulouse
  • Germany
      • Mainz, Germany, 55131
        • Johannes Gutenberg Universitaet Mainz
      • Muenchen, Germany, 80636
        • Deutsches Herzzentrum Muenchen (DHM)
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht
  • Spain
      • Barcelona, Spain, 08035
        • Vall d'Hebron University Hospital - Barcelona
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Royal Victoria Hospital Belfast
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elisabeth Hospital Birmingham
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 5BE
        • Brighton and Sussex University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Edwards CENTERA THV
Device: Transcatheter Aortic Valve Replacement (TAVR)
TAVR with the Edwards CENTERA THV System and accessories

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: 30 days
All-cause mortality at 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Prof. Hermann Reichenspurner, UKE Hamburg-Eppendorf - University Heart Center
  • Principal Investigator: Prof.Dr. Stephan Windecker, Inselspital, Klinik für Kardiologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Actual)

August 14, 2019

Study Completion (Actual)

August 20, 2024

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Estimated)

November 4, 2024

Last Update Submitted That Met QC Criteria

October 31, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortic Valve Stenosis

Clinical Trials on Transcatheter Aortic Valve Replacement (TAVR)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe