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Abbott Structural Heart Device Registry
Who can join
All ages · All sexes
Full eligibility criteria
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 be followed. Exclusion Criteria: 1\. Subject is participating in another clinical study that would affect the results of this Registry.
About the study
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.
What is being tested
- Amplatzerâ„¢ Occlusion Devices (device)
- Epicâ„¢ Surgical Tissue Heart Valve devices (device)
Sponsor: Abbott Medical Devices · Participants: 2,500 · Started: Aug 21, 2024
Contact the study team
- Laetitia Beullens · Phone: +32 277 46 937
- Kayla Dellefratte · Phone: +16692149748
Official record on ClinicalTrials.gov — NCT06590467
Locations in the U.S.
| California | USC University Hospital, Los Angeles (Not yet recruiting) |
| District of Columbia | MedStar Washington Hospital Center, Washington D.C. (Not yet recruiting) |
| Florida | Baptist Hospital of Miami, Miami (Not yet recruiting) |
| Missouri | Washington University School of Medicine, St Louis (Not yet recruiting) |
| New Jersey | Robert Wood Johnson University Hospital, New Brunswick |
| New York | Mount Sinai Hospital, New York New York Presbyterian Hospital/Cornell University, New York (Not yet recruiting) |
| Ohio | The Cleveland Clinic Foundation, Cleveland (Not yet recruiting) |
| Pennsylvania | University of Pennsylvania, Philadelphia (Not yet recruiting) UPMC, Pittsburgh |
| Virginia | Sentara Norfolk General Hospital, Norfolk |
| Washington | University of Washington Medical Center, Seattle (Not yet recruiting) |
| Wisconsin | Mayo Clinic Health System - Eau Claire Hospital, Inc., Eau Claire (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.