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
Verified date | October 2023 |
Source | Edwards Lifesciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Edwards Lifesciences |
Denmark, France, Germany, Netherlands, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-Cause Mortality | All-cause mortality at 30 days | 30 days |
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