Registry for Abbott's heart devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Robert Wood Johnson University Hospital
  New Brunswick, New Jersey, United States Recruiting
• Mount Sinai Hospital
  New York, New York, United States Recruiting
• Upmc
  Pittsburgh, Pennsylvania, United States Recruiting
• Sentara Norfolk General Hospital
  Norfolk, Virginia, United States Recruiting
• Odense University Hospital
  Odense, Southern Denmark, Denmark Recruiting
• Tartu University Hospital
  Tartu, Tartu, Estonia Recruiting

Study contacts

• Study coordinator: Laetitia Beullens
• Email: laetitia.beullens@abbott.com
• Phone: +32 277 46 937

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.