Actively Recruiting

All Genders
NCT06590467

Abbott Structural Heart Device Registry

Led by Abbott Medical Devices · Updated on 2026-04-13

2500

Participants Needed

28

Research Sites

792 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Abbott Structural Heart Device Registry

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Subject is participating in another clinical study that would affect the results of this Registry.

AI-Screening

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Trial Site Locations

Total: 28 locations

1

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States, 08901

Not Yet Recruiting

2

Mount Sinai Hospital

New York, New York, United States, 10029

Not Yet Recruiting

3

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Not Yet Recruiting

4

UPMC

Pittsburgh, Pennsylvania, United States, 15213

Not Yet Recruiting

5

Sentara Norfolk General Hospital

Norfolk, Virginia, United States, 23507

Not Yet Recruiting

6

Odense University Hospital

Odense, Southern Denmark, Denmark, 5000

Actively Recruiting

7

Tartu University Hospital

Tartu, Tartu, Estonia, 50406

Actively Recruiting

8

CHRU Hopital de Pontchaillou

Rennes, Brittan, France, 35033

Actively Recruiting

9

Centre Médico Chirurgical Marie Lannelongue

Le Plessis-Robinson, France, 92350

Actively Recruiting

10

Hopital Haut Leveque

Pessac, France, 33604

Actively Recruiting

11

Deutsches Herzzentrum München des Freistaates Bayern

München, Bavaria, Germany, 80636

Actively Recruiting

12

Klinikum Links der Weser

Bremen, Free Hanseatic City of Bremen, Germany, 28277

Actively Recruiting

13

Universitatsklinikum Jena

Jena, Germany, Germany, 07747

Actively Recruiting

14

Städt. Klinikum Braunschweig gGmbH

Braunschweig, L Saxon, Germany, 38126

Actively Recruiting

15

Deutsches Herzzentrum der Charité

Berlin, State of Berlin, Germany, 13353

Actively Recruiting

16

Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG

Bad Rothenfelde, Germany, 32545

Actively Recruiting

17

Children's Health Ireland (CHI)

Crumlin, Dublin, Ireland, D12N512

Actively Recruiting

18

IRCCS Policlinico San Donato - Cardio

San Donato Milanese, Lombardy, Italy, 20097

Actively Recruiting

19

Policlinico San Donato

San Donato Milanese, Lombardy, Italy, 20097

Actively Recruiting

20

A.O.U. Citta della Salute e della Scienza di Torino

Turin, Piedmont, Italy, 10126

Actively Recruiting

21

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany, Italy, 56126

Actively Recruiting

22

Slaskie Centrum Chorob Serca

Zabrze, Silesian Voivodeship, Poland, 41-800

Actively Recruiting

23

Hospital Infantil Sant Joan De Deu

Esplugues de Llobregat, Catalonia, Spain, 08950

Actively Recruiting

24

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain, 33011

Actively Recruiting

25

Hospital Virgen de Rocio

Seville, Spain, Spain, 41013

Actively Recruiting

26

Hospital Universitario de la Paz - Pediatrico

Madrid, Spain, 28046

Actively Recruiting

27

Royal Brompton Hospital

London, UK, United Kingdom, SW3 6NP

Actively Recruiting

28

St. Thomas Hospital

London, United Kingdom, SE1 7EH

Actively Recruiting

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Research Team

L

Laetitia Beullens

CONTACT

K

Kayla Dellefratte

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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