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

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ClinicalTrials.gov Identifier: NCT03699345
Recruitment Status : Recruiting
First Posted : October 8, 2018
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
A post market clinical trial to monitor and review the performance and outcomes of the Edwards CENTERA Transcatheter Heart Valve (THV) in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

Condition or disease Intervention/treatment
Aortic Valve Stenosis Device: Transcatheter Aortic Valve Replacement (TAVR)

Detailed Description:
A prospective, international, single arm, multi-center post market clinical follow-up study to monitor and review device performance and outcomes 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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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve Sytem
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: 30 days ]
    All-cause mortality at 30 days post index-procedure


Secondary Outcome Measures :
  1. Life Threatening and Major Bleeding [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699345


Contacts
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Contact: Selma Hadamer +41 22 787 44 21 selma_hadamer@edwards.com

Locations
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Denmark
Aarhus University Hospital, Skejby Recruiting
Aarhus, Denmark, 8200
France
Clinique Pasteur Toulouse Recruiting
Toulouse Cedex 3, France, 31076
Germany
Charite - Universitaetsmedizin Recruiting
Berlin, Germany, 10117
Johannes Gutenberg Universitaet Mainz Recruiting
Mainz, Germany, 55131
Deutsches Herzzentrum Muenchen (DHM) Recruiting
Muenchen, Germany, 80636
Netherlands
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Spain
Hospital Universitario Central de Asturias Recruiting
Asturias, Spain, 33011
Vall d'Hebron University Hospital - Barcelona Recruiting
Barcelona, Spain, 08035
Switzerland
Inselspital Bern Recruiting
Bern, Switzerland, 3010
HerzKlinik Hirslanden HKH Recruiting
Zuerich, Switzerland, 8032
United Kingdom
Brighton and Sussex University Hospital Recruiting
Brighton, East Sussex, United Kingdom, BN2 5BE
Royal Victoria Hospital Belfast Recruiting
Belfast, United Kingdom, BT12 6BA
Queen Elisabeth Hospital Birmingham Recruiting
Birmingham, United Kingdom, B15 2TH
Royal Infirmary of Edinburgh Recruiting
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Prof. Hermann Reichenspurner UKE Hamburg-Eppendorf - University Heart Center
Principal Investigator: Prof.Dr. Stephan Windecker Inselspital, Klinik für Kardiologie

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03699345     History of Changes
Other Study ID Numbers: 2017-07
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Edwards Lifesciences:
CENTERA
THV
Transcatheter Heart Valve

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction