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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.
The Abbott SH Device Registry is designed to confirm the safety and performance of commercially available Abbott SH devices as they are used in routine hospital practice or SOC procedures. Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the following timeframes:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amplatzer |
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| Cardiac Surgery (The ENDURE Study) | Approximately 1,800 subjects implanted with at least one applicable Abbott surgical tissue heart valve (THV) will be enrolled and followed for 10 years. The minimum required sample sizes for each THV model are listed below. Approximately N=100 Epic Max enrollments will occur in the United States. A combined total of approximately N=1000 subjects will be enrolled globally across the Epic Elite (aortic and mitral) and Epic Supra G3 models.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amplatzer™ Occlusion Devices | Device | The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | The primary safety endpoint will be the proportion of subjects with device- and/or procedure-related serious adverse events (SAEs) occurring within 7 days of the procedure. | 7 days |
| Primary Effectiveness Endpoint | The primary effectiveness endpoint will be the proportion of procedures that achieved technical success, defined as completion of the procedure with an applicable Abbott SH device implanted | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
1. Subject is participating in another clinical study that would affect the results of this Registry.
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This Registry is open to enroll subjects of all genders and ages from the general population who undergo a procedure that use at least one Abbott SH device included in this Registry (including unsuccessful implants). Subjects must meet all eligibility criteria and provide written informed consent prior to sites conducting any investigation-specific procedures not considered standard of care.
Patients will be screened for eligibility and willingness to participate prior to the procedure or, if enrolled retrospectively, within the timeframe specified in the device-specific appendices of the protocol (Amplatzer cohort: consent within 7days of procedure // Cardiac Surgery (The ENDURE Study) cohort: consent within 6 months (183 days) of the implant procedure)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laetitia Beullens | Contact | +32 277 46 937 | laetitia.beullens@abbott.com | |
| Kayla Dellefratte | Contact | +16692149748 | kayla.dellefratte@abbott.com |
| Name | Affiliation | Role |
|---|---|---|
| Mary Seale | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | Recruiting | New Brunswick | New Jersey | 08901 | United States |
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| Epic™ Surgical Tissue Heart Valve devices | Device | 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. |
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| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
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| University of Pennsylvania | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| UPMC | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |
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| Odense University Hospital | Recruiting | Odense | Southern Denmark | 5000 | Denmark |
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| Tartu University Hospital | Recruiting | Tartu | Tartu | 50406 | Estonia |
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| CHU Rennes, Pontchaillou | Recruiting | Rennes | Brittan | 35033 | France |
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| Centre Médico Chirurgical Marie Lannelongue | Recruiting | Le Plessis-Robinson | 92350 | France |
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| Hopital Haut Leveque | Recruiting | Pessac | 33604 | France |
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| Deutsches Herzzentrum München des Freistaates Bayern | Recruiting | München | Bavaria | 80636 | Germany |
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| Klinikum Links der Weser | Recruiting | Bremen | Free Hanseatic City of Bremen | 28277 | Germany |
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| Universitatsklinikum Jena | Recruiting | Jena | Germany | 07747 | Germany |
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| Städt. Klinikum Braunschweig gGmbH | Recruiting | Braunschweig | L Saxon | 38126 | Germany |
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| Deutsches Herzzentrum der Charité | Recruiting | Berlin | State of Berlin | 13353 | Germany |
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| Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG | Recruiting | Bad Rothenfelde | 32545 | Germany |
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| Children's Health Ireland (CHI) | Recruiting | Crumlin | Dublin | D12N512 | Ireland |
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| IRCCS Policlinico San Donato - Cardio | Recruiting | San Donato Milanese | Lombardy | 20097 | Italy |
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| Policlinico San Donato | Recruiting | San Donato Milanese | Lombardy | 20097 | Italy |
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| A.O.U. Citta della Salute e della Scienza di Torino | Recruiting | Turin | Piedmont | 10126 | Italy |
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| Azienda Ospedaliero Universitaria Pisana | Recruiting | Pisa | Tuscany | 56126 | Italy |
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| Slaskie Centrum Chorob Serca | Recruiting | Zabrze | Silesian Voivodeship | 41-800 | Poland |
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| Hospital Infantil Sant Joan De Deu | Recruiting | Esplugues de Llobregat | Catalonia | 08950 | Spain |
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| Hospital Universitario Central de Asturias | Recruiting | Oviedo | Principality of Asturias | 33011 | Spain |
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| Hospital Virgen de Rocio | Recruiting | Seville | Spain | 41013 | Spain |
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| Hospital Universitario de la Paz - Pediatrico | Recruiting | Madrid | 28046 | Spain |
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| Royal Brompton Hospital | Recruiting | London | UK | SW3 6NP | United Kingdom |
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| St. Thomas Hospital | Recruiting | London | SE1 7EH | United Kingdom |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D006344 | Heart Septal Defects, Atrial |
| D054092 | Foramen Ovale, Patent |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D055989 | Septal Occluder Device |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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