Sorin Universal REgistry on Aortic Valve Replacement

Stopped early

Conditions studied: Aortic Valve Disease, Aortic Stenosis

In brief

Multi-center, International, Prospective, Non comparative, Non randomized, Open label. 5,000 patients to be enrolled approximately worldwide. The objective of this registry is to collect safety and clinical performance post market data related to the procedure and follow-up of the Sorin Group aortic valve devices in accordance with the Instructions for Use (IFU). This observational global registry is intended to collect data without requiring any deviation from the standard of care and IFU in each participating center. The participating centers shall include those patients that have provided their informed consent to participate in this registry in accordance with the local applicable regulations.

Key facts

Study ID

NCT02679404

Run by

Corcym S.r.l

People needed

2758

Starts

2015-05-01

Expected to finish

2021-03-01

Last updated by the study team

2024-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients must provide written or oral informed consent to participate in the registry depending on the local regulations.
• Patients having received a Sorin Group aortic valve device in accordance with the IFU
• Exclusion Criteria: NA

Where it is running

• River City Clinical Research — Jacksonville, Florida, United States
• Columbia University Hospital — New York, New York, United States
• Mount Carmel Hospital — Columbus, Ohio, United States
• Baylor Scott and White Research Institute — Plano, Texas, United States
• Melbourne Private Hospital — Melbourne, Australia
• Royal Melbourne Hospital — Melbourne, Australia
• Hospital Salzburg — Salzburg, Austria
• UCL St Luc — Brussels, Belgium
• CHU Liège — Liège, Belgium
• CHR Namur — Namur, Belgium
• Private cardiac center - Burgas — Burgas, Bulgaria
• Foothill Medical Centre - Calgary, Alberta — Calgary, Canada
• Center of Cardiovascular Surgery and Transplantation Brno — Brno, Czechia
• IKEM - Prague — Prague, Czechia
• CHU Bordeaux — Bordeaux, France
• Clinique Saint Augustin — Bordeaux, France
• CHU Clermont-Ferrand — Clermont-Ferrand, France
• Clinique la Protestante — Lyon, France
• CHU La Timone — Marseille, France
• CHU Rennes — Rennes, France
• Universitätsklinikum Magdeburg — Magdeburg, Germany
• Nuremberg Hospital — Nuremberg, Germany
• Sheba Medical Center — Tel Litwinsky, Israel
• Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo — Alessandria, Italy
• Princeton Baptist Med Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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