Condition: Heart Diseases · ASD - Atrial Septal Defect · VSD - Muscular Ventricular Septal Defect · Sponsor: Abbott Medical Devices
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.
This description comes directly from the study's public registry record.
Laetitia Beullens · +32 277 46 937 · laetitia.beullens@abbott.com
Kayla Dellefratte · +16692149748 · kayla.dellefratte@abbott.com
Always discuss trial participation with your own doctor first.
| Robert Wood Johnson University Hospital | New Brunswick, New Jersey, United States | Recruiting |
| Mount Sinai Hospital | New York, New York, United States | Recruiting |
| University of Pennsylvania | Philadelphia, Pennsylvania, United States | Not Yet Recruiting |
| UPMC | Pittsburgh, Pennsylvania, United States | Recruiting |
| Sentara Norfolk General Hospital | Norfolk, Virginia, United States | Recruiting |
| Odense University Hospital | Odense, Southern Denmark, Denmark | Recruiting |
| Tartu University Hospital | Tartu, Tartu, Estonia | Recruiting |
| CHU Rennes, Pontchaillou | Rennes, Brittan, France | Recruiting |
| Centre Médico Chirurgical Marie Lannelongue | Le Plessis-Robinson, France | Recruiting |
| Hopital Haut Leveque | Pessac, France | Recruiting |
| Deutsches Herzzentrum München des Freistaates Bayern | München, Bavaria, Germany | Recruiting |
| Klinikum Links der Weser | Bremen, Free Hanseatic City of Bremen, Germany | Recruiting |
+ 16 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06590467