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Medtronic Cardiac Surgery PMCF Registry

This study, called the Medtronic Cardiac Surgery PMCF Registry, is looking at how well Medtronic's heart valve products perform in patients after surgery. It's for people with heart valve disease who have either had or are going to have surgery to repair or replace a heart valve using one of these products. There's no specific 'phase' because it's about observing how devices work in real-world use, rather than testing new treatments. The main goal is to gather information to ensure the products continue to be safe and effective, helping Medtronic improve them if needed. It's an important way to monitor medical devices once they are already available for use.

At a glance

Status
Recruiting
Sponsor
Medtronic Cardiac Surgery
Enrolment target
2,700
Start
02 Dec 2019
Estimated completion
31 Dec 2039

What is this study about?

This registry is a way for Medtronic, a medical device company, to keep an eye on their heart valve products after they've been used in patients. Think of it like a long-term check-up for their products. When someone has surgery to fix or replace a heart valve, and a Medtronic product is used, their experience and recovery can provide valuable information.

The main purpose of this study is to collect details about how these surgical heart valve repair and replacement products work in everyday situations. This helps Medtronic understand how well the products are performing, if there are any unexpected issues, and ultimately, helps them ensure the products are safe and effective for patients with heart valve disease. This type of monitoring is crucial for all medical devices once they are being used widely.

By gathering this information, Medtronic can continuously assess the performance of their devices. This long-term monitoring contributes to patient safety and can lead to improvements in future heart valve treatments. It's not about trying out new treatments, but rather observing and learning from treatments that are already in use.

Key takeaways

  • This study collects information about Medtronic heart valve devices after surgery.
  • It helps ensure the devices are safe and work well for people with heart valve disease.
  • You don't get new medicines or treatments by joining.
  • Participation involves sharing medical information from your usual care.
  • It contributes to improving future heart valve treatments.
  • You can choose to join or leave the study at any time.

Who may be eligible?

This study is for adults who have a heart valve problem and are either planning to have surgery or have recently had surgery to fix or replace a heart valve using a Medtronic product. You would generally need to be able to provide written permission to join the study.

You wouldn't be able to join if you might not be available for check-ups in the future, if local laws prevent your participation, or if you're already in another study involving a new medication or device that might make it hard to tell what effects are from which study. Essentially, they need to be sure they can follow up with you reliably and that the information collected will be clear and useful for understanding their heart valve products.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Have you been diagnosed with heart valve disease?
  2. Are you having or have you recently had heart valve surgery using a Medtronic product?
  3. Are you able to give written permission to join the study?
  4. Are you able to attend your regular follow-up appointments?
  5. Are you NOT currently part of another study for an unapproved drug or device?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this registry, it mainly involves allowing your healthcare information related to your heart valve surgery and the Medtronic product used to be collected. This information will come from your medical records and any follow-up appointments you have as part of your usual care.

There aren't any extra visits or special medications you'd need to take just for this study. The researchers will simply gather details about your health and how you're doing after your surgery from your existing medical care. The length of time you're followed will depend on the study's plan for your specific device, but it's focused on understanding long-term outcomes.

Your involvement helps them understand the device's performance over time without adding new procedures or burdens to your normal care.

Potential risks and benefits

The main benefit of taking part in this registry is helping improve understanding of how Medtronic heart valve products work in real-world patients. This can contribute to better future treatments for people with heart valve disease. For you personally, there are no direct medical benefits, as it doesn't involve new medicines or procedures. The main risk is a very small chance that your personal information could be accidentally shared, though strict measures are in place to protect your privacy and keep your details confidential. Taking part is completely voluntary, and you can withdraw your permission at any time without affecting your medical care.

Locations (26)

  • WellStar Kennestone Hospital
    Verified postcode
    Marietta, United States· Recruiting
  • University of Michigan
    Verified postcode
    Ann Arbor, United States· Recruiting
  • Mount Sinai Medical Center
    Verified postcode
    New York, United States· Recruiting
  • Saint Francis Hospital
    Verified postcode
    Roslyn, United States· Withdrawn
  • Saint Josephs Hospital Health Center
    Verified postcode
    Syracuse, United States· Recruiting
  • Duke University Medical Center
    Verified postcode
    Durham, United States· Recruiting
  • University Hospitals Cleveland
    Verified postcode
    Cleveland, United States· Recruiting
  • University of Pittsburgh Medical Center UPMC Presbyterian
    Verified postcode
    Pittsburgh, United States· Recruiting
  • Baylor St. Luke's Medical Center
    Verified postcode
    Houston, United States· Recruiting
  • The Heart Hospital Plano
    Verified postcode
    Plano, United States· Recruiting
  • Inova
    Verified postcode
    Falls Church, United States· Recruiting
  • Allgemeines Krankenhaus - Universitätskliniken Wien
    Verified postcode
    Vienna, Austria· Recruiting

Common questions

What is a registry in this context?

A registry is a study that collects information about patients and treatments over time. It helps researchers understand how medical devices perform in many different people after they've been made available for use.

Will taking part change my medical treatment?

No, taking part in this registry will not change your medical treatment or the care you receive for your heart valve condition. It only involves collecting information about your existing care.

Who is running this study?

This study is being run by Medtronic, a company that makes medical devices, to monitor their heart valve products after they are used by patients.

Do I have to do anything special?

No, you don't have to do anything special. The study will gather information from your medical records as part of your ongoing care related to your heart valve surgery.

What kind of heart valve problems are included?

This study is for people with various kinds of heart valve disease who are having or have had surgery using specific Medtronic products to fix or replace their heart valves.

How to find out more

Lisa Slusser

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Medtronic Cardiac Surgery PMCF Registry…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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