- Abbott Structural Heart Device Registry — Recruiting • Cardiology / Cardiovascular • NCT06590467.
- What is being tested: Safety and performance of Abbott's structural heart devices in real-world clinical practice, using data collected from routine hospital procedures rather than controlled trial settings.
- Patient eligibility: Adults undergoing standard-of-care procedures for structural heart conditions treated with Abbott structural heart devices across participating UK healthcare centres.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
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- 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.