Registry for patients receiving heart valve surgery products

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

This registry is designed to monitor the safety and effectiveness of surgical heart valve repair and replacement products in patients. It collects data from individuals who are either currently receiving or have received these products, ensuring ongoing post-market surveillance. The registry aims to gather comprehensive information that can help improve patient outcomes and inform future medical practices related to heart valve treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
2. Patient has or is intended to receive or be treated with an eligible product
3. Patient is within enrollment window of treatment/therapy received at the time of their initial Registry enrollment, or meets criteria for retrospective enrollment

Exclusion Criteria:

1. Patient who is, or is expected to be, inaccessible for follow-up
2. Patient prohibited from participation by local law
3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or device study that may confound results

Where it's running

• WellStar Kennestone Hospital
  Marietta, Georgia, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Mount Sinai Medical Center
  New York, New York, United States Recruiting
• Saint Josephs Hospital Health Center
  Syracuse, New York, United States Recruiting
• Duke University Medical Center
  Durham, North Carolina, United States Recruiting
• University Hospitals Cleveland
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Franceen Maroney
• Email: rs.hvtpmcfregistry@medtronic.com
• Phone: 1-800-328-2518

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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.