Lead Evaluation for Defibrillation and Reliability Post Approval Study
This study, called LEADR PAS, is observing how a specific medical device, the OmniaSecure™ defibrillation lead, performs once it's available for general use. These leads are tiny wires that help control very fast or irregular heartbeats (tachyarrhythmia). The main goal is to keep track of its safety and how well it works over time in real-world situations. It’s not testing a new device, but rather gathering information on one that's already in use. Patients who receive this lead as part of their standard care will have their health and the device's performance monitored. This helps doctors and manufacturers ensure the device continues to be safe and effective for people needing it.
At a glance
What is this study about?
This study is called the LEADR PAS, which stands for "Lead Evaluation for Defibrillation and Reliability Post Approval Study." It's being run by Medtronic, the company that makes a specific type of medical device called an OmniaSecure™ defibrillation lead. These leads are like tiny wires that are a crucial part of an implantable heart device. They are designed to deliver a small electric shock to correct very fast or irregular heartbeats, a condition sometimes called tachyarrhythmia, which can be dangerous.
Unlike trials that test new medicines or devices, this study is observing how the OmniaSecure™ defibrillation lead performs after it has already been approved and is being used by patients in their regular healthcare. Think of it like watching how a new car model performs once it's on the road with many drivers, rather than just in test drives. The main purpose is to make sure the device continues to be safe and effective for patients in their everyday lives over many years.
Doctors and the company want to collect ongoing information about these leads. By following a large group of patients over a long period, they can gather important details about the device's reliability and any potential issues that might come up. This information helps them confirm that the device is working as expected and allows them to make any necessary improvements to ensure the best possible care for patients.
Key takeaways
- This study tracks the long-term safety of a specific heart device.
- It helps ensure the OmniaSecure™ defibrillation lead works well for patients.
- Participation involves routine doctor's visits, not extra procedures.
- The study observes a device already in use, not a new treatment.
- Your contribution helps improve care for others with heart conditions.
- You can stop participating at any time.
Who may be eligible?
To be part of this study, you would first need to agree to participate by signing a consent form. This makes sure you understand what the study involves.
Next, you must have either just received, or be about to receive, an OmniaSecure™ defibrillation lead as part of your heart treatment. It's important that your doctor plans for you to have this specific lead.
You would not be able to join if it would be difficult for doctors to keep in touch with you for follow-up appointments. Also, if you are already taking part in another medical study that might affect the results of this one, you might not be able to join. Finally, any local laws or rules could also affect whether you can participate.
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.
- Have I signed a consent form to join?
- Am I receiving, or about to receive, an OmniaSecure™ defibrillation lead?
- Can doctors easily contact me for follow-up appointments?
- Am I currently in any other medical studies that might prevent me from joining this one?
What does participation involve?
If you decide to join this study, it would mostly involve your regular doctor's appointments. You would be followed for as long as you have the defibrillation lead implanted, or until the study officially ends, or if you choose to leave the study at any time.
This means you would attend your usual scheduled check-ups, typically at least once a year. Your doctors would keep an eye on your health and how the defibrillation lead is working, just as they would as part of your routine care. If there are any important health events, those would also be recorded. The study aims to follow patients for many years, potentially for the entire lifetime of the device.
Potential risks and benefits
Locations (73)
- The University of Alabama at BirminghamVerified postcodeBirmingham, United States
- Stanford Hospital & ClinicsVerified postcodeStanford, United States
- COR HealthcareVerified postcodeTorrance, United States
- Childrens Hospital ColoradoVerified postcodeAurora, United States
- Hartford HosptialVerified postcodeHartford, United States
- Childrens National Medical CenterVerified postcodeWashington D.C., United States
- Heart Rhythm SolutionsVerified postcodeHollywood, United States
- Cardiovascular Institute of Northwest FloridaVerified postcodePanama City, United States
- Heart & Vascular Institute of FloridaVerified postcodeSafety Harbor, United States
- Intercoastal Medical GroupVerified postcodeSarasota, United States
- University of South Florida Health (USF)Verified postcodeTampa, United States
- WellStar Research InstituteVerified postcodeMarietta, United States
Common questions
What is a defibrillation lead?
It's a special wire that's part of a heart device. It helps correct very fast or irregular heartbeats by delivering a small electric pulse.
Is this a trial for a new treatment?
No, this study is observing how a defibrillation lead that is already approved and in use performs in real-world patients over time.
How long will I be in the study?
You'll be followed for as long as you have the device, or until the study ends, or if you choose to stop participating.
Do I need extra appointments for this study?
Generally, you will attend your regular, routine follow-up appointments with your doctor, typically at least once a year.
Can I leave the study at any time?
Yes, you are free to withdraw from the study at any point without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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