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Registry for Abbott's heart devices

Abbott Structural Heart Device Registry

Observational Abbott Medical Devices · NCT06590467

This study is collecting information to see how safe and effective Abbott's heart devices are for patients getting them implanted in real-life hospital settings.

Quick facts

Study typeObservational
Enrollment2500 (estimated)
SexAll
SponsorAbbott Medical Devices Industry-sponsored
Locations28 sites (New Brunswick, New Jersey and 27 other locations)
Trial IDNCT06590467 on ClinicalTrials.gov

What this trial studies

The Abbott Structural Heart Registry aims to confirm the safety and performance of Abbott's structural heart devices in real-world clinical settings. It involves collecting data from routine hospital practices and standard-of-care procedures for patients undergoing implant attempts with these devices. Eligible patients will be enrolled either prospectively or retrospectively, with follow-up data collected at various intervals post-procedure. The registry will span approximately 5 years and include around 500 subjects per year across multiple sites worldwide.

Who should consider this trial

Good fit: Ideal candidates include patients scheduled for an implant attempt using Abbott Structural Heart devices or those who have recently undergone such a procedure.

Not a fit: Patients currently participating in other clinical studies that may influence the results of this registry may not benefit from participation.

Why it matters

Potential benefit: If successful, this registry could enhance the understanding of Abbott's heart devices' safety and effectiveness, leading to improved patient outcomes.

How similar studies have performed: Other observational registries for medical devices have shown success in confirming safety and performance, making this approach well-established.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

New Brunswick, New Jersey and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
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Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.