Abbott Structural Heart Device Registry
Abbott Medical Devices
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.
Description
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: * 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 i…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. 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 b…
Interventions
- DeviceAmplatzer™ Occlusion Devices
The Amplatzer™ Occluders are devices intended for the occlusion of multiple septal heart defects.
- DeviceEpic™ 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.
Locations (28)
- Robert Wood Johnson University HospitalNew Brunswick, New Jersey
- Mount Sinai HospitalNew York, New York
- University of PennsylvaniaPhiladelphia, Pennsylvania
- UPMCPittsburgh, Pennsylvania
- Sentara Norfolk General HospitalNorfolk, Virginia
- Odense University HospitalOdense, Southern Denmark