CompletedNo phase
CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System
Key facts
- Who runs it
- Edwards Lifesciences
- Where
- Denmark, France, Germany, Netherlands, Spain, and United Kingdom11 sites in 6 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 87 people enrolled
- Started
- 7 Jan 2019
- Ended
- 20 Aug 2024
- Type of study
- Observational
- Treatments tested
- Transcatheter Aortic Valve Replacement (TAVR)
- Record updated
- 4 November 2024
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Inability to tolerate anticoagulation/antiplatelet therapy
- Known hypersensitivity to Nitinol (nickel or titanium)
- Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
This trial has no sites in United States.
It has sites in 6 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Edwards CENTERA THV
Treatment: Transcatheter Aortic Valve Replacement (TAVR)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve System
- Record updated
- 4 November 2024