Abbott Structural Heart Device Registry

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
View:

• 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.

Locations
Other Locations
Estonia
Tartu University Hospital
RECRUITING
Tartu
France
Centre Médico Chirurgical Marie Lannelongue
RECRUITING
Le Plessis-robinson
Hopital Haut Leveque
RECRUITING
Pessac
CHRU Hopital de Pontchaillou
RECRUITING
Rennes
Germany
Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG
RECRUITING
Bad Rothenfelde
Deutsches Herzzentrum der Charité
RECRUITING
Berlin
Städt. Klinikum Braunschweig gGmbH
RECRUITING
Braunschweig
Universitatsklinikum Jena
RECRUITING
Jena
Deutsches Herzzentrum München des Freistaates Bayern
RECRUITING
München
Italy
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
IRCCS Policlinico San Donato - Cardio
RECRUITING
San Donato Milanese
Policlinico San Donato
RECRUITING
San Donato Milanese
A.O.U. Citta della Salute e della Scienza di Torino
RECRUITING
Turin
Poland
Slaskie Centrum Chorob Serca
RECRUITING
Zabrze
Spain
Hospital Infantil Sant Joan De Deu
RECRUITING
Esplugues De Llobregat
Hospital Universitario de la Paz - Pediatrico
RECRUITING
Madrid
Hospital Virgen de Rocio
RECRUITING
Seville
United Kingdom
Royal Brompton Hospital
RECRUITING
London
St. Thomas Hospital
RECRUITING
London
Contact Information
Primary
Laetitia Beullens
laetitia.beullens@abbott.com
+32 277 46 937
Backup
Kayla Dellefratte
kayla.dellefratte@abbott.com
+16692149748
Time Frame
Start Date: 2024-08-21
Estimated Completion Date: 2039-11
Participants
Target number of participants: 2500
Treatments
Amplatzer
* ASO: ≥50 cases/year~* ASD-MF: ≥50 cases/year~* ADO: ≥50 cases/year~* ADO II: ≥50 cases/year~* Piccolo: ≥50 cases/year~* MuVSD: Up to 50 cases/year~* PI-VSD: Up to 50 cases/year~* Talisman/TDS: ≥100 cases/year~* TorqVue Delivery Systems Group 1 (ATV/ITV/EITV/TV2): 250 cases/year across different occluders~* TorqVue Delivery Systems Group 2 (TVLP/TVLPC): 100 cases/year across different occluders~* SB II:100 PFO cases/year \& 100 ASD cases/year~* GW: 200 cases/year
Cardiac Surgery
It is anticipated that approximately 830 subjects implanted with at least one applicable Abbott surgical tissue heart valve (THV) will be enrolled and followed for 10 years.~* Approximately 225 subjects receiving Epic Plus mitral valves~* Approximately 150 subjects receiving Epic Plus aortic valves~* Approximately 170 subjects receiving Epic Plus Supra aortic valves~* Approximately 285 subjects receiving Epic Max aortic valves
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov