Abbott Structural Heart Device Registry

Launched by ABBOTT MEDICAL DEVICES · Sep 9, 2024

Keywords

ClinConnect Summary

The Abbott Structural Heart Device Registry is a study aimed at evaluating the safety and effectiveness of certain heart devices made by Abbott. These devices are used to treat various heart conditions, such as holes in the heart (like atrial septal defect and ventricular septal defect) and valve problems. The study involves collecting information from hospitals about how these devices are performing in real-life situations after they have already been approved for use. This data will help ensure that the devices continue to meet safety standards set by health authorities.

To be eligible for this study, participants should be scheduled to receive one of the Abbott heart devices or have already had one implanted recently. They must also agree to follow up with their healthcare providers as recommended. Participants will be asked to give their consent to join the study, and if they meet the criteria, they can contribute valuable information that helps improve heart care for everyone. The study is currently looking for participants of all ages and genders.

Gender

ALL

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.