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Abbott Structural Heart Device Registry
Sponsor: Abbott Medical Devices
Summary
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting. The Registry primarily involves gathering data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures must be commercially available to the participating site. A list of specific devices covered by the Registry are available upon request from the Sponsor. Data generated by the Registry will be used to meet regulatory requirements, such as the European Union Medical Device Regulations 2017/745, that require active post-market clinical follow-up (PMCF) for all commercially available devices.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
2500
Start Date
2024-08-21
Completion Date
2039-11
Last Updated
2026-01-30
Healthy Volunteers
No
Conditions
Interventions
Amplatzer™ Occlusion Devices
The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.
Epic™ Surgical Tissue Heart Valve devices
The Epic™ valves are indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic/mitral heart valve. It may also be used as a replacement for a previously implanted aortic/mitral prosthetic heart valve.
Locations (27)
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
UPMC
Pittsburgh, Pennsylvania, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Odense University Hospital
Odense, Southern Denmark, Denmark
Tartu University Hospital
Tartu, Tartu, Estonia
CHRU Hopital de Pontchaillou
Rennes, Brittan, France
Centre Médico Chirurgical Marie Lannelongue
Le Plessis-Robinson, France
Hopital Haut Leveque
Pessac, France
Deutsches Herzzentrum München des Freistaates Bayern
München, Bavaria, Germany
Klinikum Links der Weser
Bremen, City state Bremen, Germany
Universitatsklinikum Jena
Jena, Germany, Germany
Städt. Klinikum Braunschweig gGmbH
Braunschweig, L Saxon, Germany
Deutsches Herzzentrum der Charité
Berlin, State of Berlin, Germany
Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG
Bad Rothenfelde, Germany
Children's Health Ireland (CHI)
Crumlin, Dublin, Ireland
IRCCS Policlinico San Donato - Cardio
San Donato Milanese, Lombardy, Italy
Policlinico San Donato
San Donato Milanese, Lombardy, Italy
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Slaskie Centrum Chorob Serca
Zabrze, Silesian Voivodeship, Poland
Hospital Infantil Sant Joan De Deu
Esplugues de Llobregat, Catalonia, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Virgen de Rocio
Seville, Spain, Spain
Hospital Universitario de la Paz - Pediatrico
Madrid, Spain
Royal Brompton Hospital
London, UK, United Kingdom
St. Thomas Hospital
London, United Kingdom