Abbott Structural Heart Device Registry
Recruiting now
Conditions studied: Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale, PIVSD - Post Infarct Muscular Ventricular Septal Defect, Valvular Heart Disease
In brief
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 facts
- Study ID
- NCT06590467
- Run by
- Abbott Medical Devices
- People needed
- 2500
- Starts
- 2024-08-21
- Expected to finish
- 2039-11-01
- Last updated by the study team
- 2026-07-09
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is expected to undergo an implant attempt using one or more Abbott Structural Heart devices covered in this Registry or has previously undergone an implant attempt within the timeframes specified in the device-specific appendices.
- Subject is willing and able to comply with the site's standard of care follow-up schedule.
- Subject is willing to provide appropriate informed consent for Registry participation. For deceased subjects enrolled retrospectively, local regulations and EC/IRB recommendations regarding consent and the protection of personal data must be followed.
You may not qualify if…
- Subject is participating in another clinical study that would affect the results of this Registry.
Where it is running
- St. Thomas Hospital — London, United Kingdom (enrolling)
- Mount Sinai Hospital — New York, New York, United States (enrolling)
- Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (enrolling)
- UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
- Sentara Norfolk General Hospital — Norfolk, Virginia, United States (enrolling)
- Odense University Hospital — Odense, Southern Denmark, Denmark (enrolling)
- Tartu University Hospital — Tartu, Tartu, Estonia (enrolling)
- CHU Rennes, Pontchaillou — Rennes, Brittan, France (enrolling)
- Centre Médico Chirurgical Marie Lannelongue — Le Plessis-Robinson, France (enrolling)
- Hopital Haut Leveque — Pessac, France (enrolling)
- Deutsches Herzzentrum München des Freistaates Bayern — München, Bavaria, Germany (enrolling)
- Klinikum Links der Weser — Bremen, Free Hanseatic City of Bremen, Germany (enrolling)
- Universitatsklinikum Jena — Jena, Germany, Germany (enrolling)
- Städt. Klinikum Braunschweig gGmbH — Braunschweig, L Saxon, Germany (enrolling)
- Deutsches Herzzentrum der Charité — Berlin, State of Berlin, Germany (enrolling)
- Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG — Bad Rothenfelde, Germany (enrolling)
- Children's Health Ireland (CHI) — Crumlin, Dublin, Ireland (enrolling)
- IRCCS Policlinico San Donato - Cardio — San Donato Milanese, Lombardy, Italy (enrolling)
- Policlinico San Donato — San Donato Milanese, Lombardy, Italy (enrolling)
- A.O.U. Citta della Salute e della Scienza di Torino — Turin, Piedmont, Italy (enrolling)
- Azienda Ospedaliero Universitaria Pisana — Pisa, Tuscany, Italy (enrolling)
- Slaskie Centrum Chorob Serca — Zabrze, Silesian Voivodeship, Poland (enrolling)
- Hospital Infantil Sant Joan De Deu — Esplugues de Llobregat, Catalonia, Spain (enrolling)
- Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain (enrolling)
- Hospital Virgen de Rocio — Seville, Spain, Spain (enrolling)
Full record on ClinicalTrials.gov
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