Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2500 participants
OBSERVATIONAL
2024-08-21
2039-11-30
Brief Summary
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Detailed Description
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* Amplatzer portion: within 7 days post-procedure
* Cardiac Surgery portion: within 6 months post-procedure.
All patients who provide informed consent and undergo an implant attempt with an applicable Abbott SH device are eligible to participate in the Registry. The Registry anticipates that approximately 500 subjects per year will be enrolled. The projected enrollment period is at least 5 years.
The Registry will be conducted at approximately 25 sites worldwide. Additional sites may be approached for participation in the Registry as needed.
Follow-up visits should align with the site's routine SOC visits for the associated procedure. Data collection will occur post-screening and consent and at post-procedure SOC follow-up visit(s). Where applicable, follow-up visits may occur over the telephone, virtually, or in-office, following SOC practice.
The follow-up duration will depend on the Abbott device(s) used during the procedure. Certain devices will utilize data collection at discharge (or 7 days post procedure, whichever comes first), short-term (1 - 3 months as applicable), a mid-term (6 months), and long-term follow-up (12 months) visits to support clinical safety and performance data requirements. Alternatively, some devices will have follow-up visits extending up to 10 years to monitor subjects throughout the devices' lifetime.
A surgical valve-specific "Line Extension Sub-Study" is included in the protocol to collect data at European sites with the intention of applying for approval in the US for 2 specific surgical aortic valve sizes (Epic Max 27mm, and the Epic Plus Supra 29mm).
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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
Amplatzer™ Occlusion Devices
The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.
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
Epic™ Surgical Tissue Heart Valve devices
The Epic™ valves are indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic/mitral heart valve. It may also be used as a replacement for a previously implanted aortic/mitral prosthetic heart valve.
Interventions
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Amplatzer™ Occlusion Devices
The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.
Epic™ Surgical Tissue Heart Valve devices
The Epic™ valves are indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic/mitral heart valve. It may also be used as a replacement for a previously implanted aortic/mitral prosthetic heart valve.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is willing and able to comply with the site's standard of care follow-up schedule.
3. 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.
Exclusion Criteria
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Ryan Palmer
Role: STUDY_DIRECTOR
Abbott
Locations
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Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
UPMC
Pittsburgh, Pennsylvania, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Odense University Hospital
Odense, Southern Denmark, Denmark
Tartu University Hospital
Tartu, Tartu, Estonia
CHRU Hopital de Pontchaillou
Rennes, Brittan, France
Centre Médico Chirurgical Marie Lannelongue
Le Plessis-Robinson, , France
Hopital Haut Leveque
Pessac, , France
Deutsches Herzzentrum München des Freistaates Bayern
München, Bavaria, Germany
Klinikum Links der Weser
Bremen, City state Bremen, Germany
Universitatsklinikum Jena
Jena, Germany, Germany
Städt. Klinikum Braunschweig gGmbH
Braunschweig, L Saxon, Germany
Deutsches Herzzentrum der Charité
Berlin, State of Berlin, Germany
Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG
Bad Rothenfelde, , Germany
Children's Health Ireland (CHI)
Crumlin, Dublin, Ireland
IRCCS Policlinico San Donato - Cardio
San Donato Milanese, Lombardy, Italy
Policlinico San Donato
San Donato Milanese, Lombardy, Italy
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Slaskie Centrum Chorob Serca
Zabrze, Silesian Voivodeship, Poland
Hospital Infantil Sant Joan De Deu
Esplugues de Llobregat, Catalonia, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Virgen de Rocio
Seville, Spain, Spain
Hospital Universitario de la Paz - Pediatrico
Madrid, , Spain
Royal Brompton Hospital
London, UK, United Kingdom
St. Thomas Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Leonard Lee, MD
Role: primary
Ismail El-Hamamsy, MD
Role: primary
Ibrahim Sultan, MD
Role: primary
Clinton Kemp, MD
Role: primary
Lars Peter Riber, Prof.
Role: primary
Arno Ruusalepp, Prof.
Role: primary
Amedeo Anselmi
Role: primary
Sebastien Hascoet, Dr.
Role: primary
Zakaria Jalal, Dr.
Role: primary
Stanimir Georgiev, Dr. med.
Role: primary
Jens Garbade, Prof. Dr. med.
Role: primary
Torsten Doenst, Prof. Dr.
Role: primary
Ingo Breitenbach, Dr. med.
Role: primary
Peter Kramer, Dr. med.
Role: primary
Nicolas Doll, Prof.
Role: primary
Damien Kenny, Prof.
Role: primary
Angelo Fabio D'Aiello, MD
Role: primary
Francesco Bedogni, MD
Role: primary
Giuseppe Annoni
Role: primary
Andrea Colli, Prof.
Role: primary
Roland Fiszer, Prof.
Role: primary
Juan Manuel Carretero Bellon
Role: primary
Jacobo Silva Guisasola
Role: primary
Jose Miguel Borrego Dominguez, Dr
Role: primary
Federico Gutierrez Larraya, Dr.
Role: primary
Alain Fraisse, Dr.
Role: primary
Matthew Jones, Dr.
Role: primary
Other Identifiers
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ABT-CIP-10415
Identifier Type: -
Identifier Source: org_study_id
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