Medtronic Cardiac Surgery PMCF Registry

Launched by MEDTRONIC CARDIAC SURGERY · Aug 28, 2019

Keywords

ClinConnect Summary

The Medtronic Cardiac Surgery PMCF Registry is a study designed to gather information about patients who have valve disease or are undergoing heart surgery. The goal of this registry is to monitor the safety and effectiveness of certain medical devices used in these treatments after they have been approved for use. Researchers are currently looking for participants to join the study, and anyone can participate regardless of gender.

To be eligible, patients must give written consent to take part and either have already received or be planning to receive a specific medical device related to their heart condition. Participants should be available for follow-up visits, and they cannot be involved in other studies that might interfere with the results. If you join this registry, you can expect to share your experiences with the treatment and receive regular check-ins from the research team to monitor your progress and health outcomes.

Gender

ALL

Eligibility criteria

• 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