Clinical trialNCT06590467RecruitingObservational

Abbott Structural Heart Device Registry

SponsorAbbott Medical DevicesEnrollment2,500ASD - Atrial Septal DefectHeart DiseasesPFO - Patent Foramen OvalePIVSD - Post Infarct Muscular Ventricular Septal DefectVSD - Muscular Ventricular Septal DefectValvular Heart Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Mary Seale
Abbott
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

36 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Denmark

Odense University Hospital
Odense, Southern Denmark, Denmark
Lars Peter Riber, Prof.
Recruiting

Estonia

Tartu University Hospital
Tartu, Tartu, Estonia
Arno Ruusalepp, Prof.
Recruiting

France

Chu Rennes, Pontchaillou
Rennes, Brittan, France
Amedeo Anselmi
Recruiting
Hôpital Marie-Lannelongue
Le Plessis-Robinson, France
Sebastien Hascoet, Dr.
Recruiting
Hopital Haut Leveque
Pessac, France
Zakaria Jalal, Dr.
Recruiting

Germany

Deutsches Herzzentrum München Des Freistaates Bayern
München, Bavaria, Germany
Stanimir Georgiev, Dr. med.
Recruiting
Klinikum Links Der Weser
Bremen, Free Hanseatic City of Bremen, Germany
Jens Garbade, Prof. Dr. med.
Recruiting
Universitatsklinikum Jena
Jena, Germany, Germany
Torsten Doenst, Prof. Dr.
Recruiting
Städt. Klinikum Braunschweig Ggmbh
Braunschweig, L Saxon, Germany
Ingo Breitenbach, Dr. med.
Recruiting
Deutsches Herzzentrum Der Charité
Berlin, State of Berlin, Germany
Peter Kramer, Dr. med.
Recruiting
Schüchtermann-Schiller´sche Kliniken Gmbh & Co. Kg
Bad Rothenfelde, Germany
Nicolas Doll, Prof.
Recruiting

Ireland

Children'S Health Ireland (chi)
Crumlin, Dublin, Ireland
Damien Kenny, Prof.
Recruiting

Italy

Irccs Policlinico San Donato - Cardio
San Donato Milanese, Lombardy, Italy
Angelo Fabio D'Aiello, MD
Recruiting
Policlinico San Donato
San Donato Milanese, Lombardy, Italy
Francesco Bedogni, MD
Recruiting
A.O.U. Citta Della Salute E Della Scienza Di Torino
Turin, Piedmont, Italy
Giuseppe Annoni
Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Andrea Colli, Prof.
Recruiting

Poland

Slaskie Centrum Chorob Serca
Zabrze, Silesian Voivodeship, Poland
Roland Fiszer, Prof.
Recruiting

Spain

Hospital Infantil Sant Joan de Deu
Esplugues de Llobregat, Catalonia, Spain
Juan Manuel Carretero Bellon
Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Jacobo Silva Guisasola
Recruiting
Hospital Virgen de Rocio
Seville, Spain, Spain
Jose Miguel Borrego Dominguez, Dr
Recruiting
Hospital Universitario de la Paz - Pediatrico
Madrid, Spain
Federico Gutierrez Larraya, Dr.
Recruiting

United Kingdom

Royal Brompton Hospital
London, UK, United Kingdom
Alain Fraisse, Dr.
Recruiting
St. Thomas Hospital
London, United Kingdom
Matthew Jones, Dr.
Recruiting

United States

Usc University Hospital
Los Angeles, California, United States
Craig Baker, MD
Not, yet, recruiting
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Thomas MacGillivray, MD
Not, yet, recruiting
Baptist Hospital of Miami
Miami, Florida, United States
Tom Nguyen, MD
Not, yet, recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Tsuyoshi Kaneko, MD
Not, yet, recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Leonard Lee, MD
Recruiting
Mount Sinai Hospital
New York, New York, United States
Ismail El-Hamamsy, MD
Recruiting
New York Presbyterian Hospital/cornell University
New York, New York, United States
Joshua Goldberg, MD
Not, yet, recruiting
the Cleveland Clinic Foundation
Cleveland, Ohio, United States
Edward Soltesz, MD
Not, yet, recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Chase Brown, MD
Not, yet, recruiting
Upmc
Pittsburgh, Pennsylvania, United States
Derek Serna Gallegos, MD
Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Clinton Kemp, MD
Recruiting
University of Washington Medical Center
Seattle, Washington, United States
Scott DeRoo, MD
Not, yet, recruiting
Mayo Clinic Health System - Eau Claire Hospital, Inc.
Eau Claire, Wisconsin, United States
Robert Wiechmann, MD
Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 21 Aug 2024
Primary completion: 31 Dec 2029
Completion: 30 Nov 2039
Last update posted: 1 Sept 2026
Registered enrollment: 2,500
Registry id: NCT06590467

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.