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NCT03699345 Clinical Trial

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

Aortic Valve Stenosis Clinical Trial

Official title:
Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve System

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03699345
Other study ID # 2017-07
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 7, 2019
Est. completion date September 2024

Study information
Verified date October 2023
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 87
Est. completion date September 2024
Est. primary completion date August 14, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Transcatheter Aortic Valve Replacement (TAVR)
TAVR with the Edwards CENTERA THV System and accessories

Locations
Country Name City State
Denmark Aarhus University Hospital, Skejby Aarhus
France Clinique Pasteur Toulouse Toulouse Cedex 3
Germany Johannes Gutenberg Universitaet Mainz Mainz
Germany Deutsches Herzzentrum Muenchen (DHM) Muenchen
Netherlands Universitair Medisch Centrum Utrecht Utrecht
Spain Vall d'Hebron University Hospital - Barcelona Barcelona
Spain Hospital Universitario Central de Asturias Oviedo
United Kingdom Royal Victoria Hospital Belfast Belfast
United Kingdom Queen Elisabeth Hospital Birmingham Birmingham
United Kingdom Brighton and Sussex University Hospital Brighton East Sussex
United Kingdom Royal Infirmary of Edinburgh Edinburgh

Sponsors (1)
Lead Sponsor Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-Cause Mortality All-cause mortality at 30 days 30 days
See also
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