The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating registry hospital.
* Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used.
Exclusion Criteria:
* Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a post-market registry and not a traditional trial testing a new treatment, can you explain what that means for me — am I receiving an experimental device, or one that's already approved and used in routine cardiac surgery?
2This registry is measuring device safety and performance — does that mean my care team will be collecting data on how the Medtronic device works in my specific case, and how might that affect the way my surgery or follow-up is managed?
3Since this study has no assigned phase, which typically means it's observational rather than interventional, would my treatment plan be any different if I participate compared to if I don't?
4What are the specific Medtronic devices being used in this registry, and are those the same devices you would already be recommending for my cardiac surgery regardless of this study?
5Are there standard cardiac surgery options outside of this registry that I should compare against before deciding whether participating makes sense for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.