Active not recruitingOBSERVATIONAL

Enlighten Study: The EV-ICD Post Approval Registry

The Enlighten Study is being run by Medtronic to check on a new heart device called an EV-ICD after it's been approved for use. This device helps treat very fast and dangerous heart rhythms. The study will look closely at how safe and effective the EV-ICD is for patients in their daily lives. It's a long-term study that will follow patients who have received the device. Doctors will keep track of their health and how the device is working during regular check-ups. The main goal is to make sure the EV-ICD is working well and safely for everyone who uses it.

At a glance

Status

Active not recruiting

Sponsor

Medtronic

Enrolment target

1,000

Start

01 Sep 2023

Estimated completion

31 Oct 2037

Ventricular Arrhythmia Tachycardia

What is this study about?

The Enlighten Study is an important project designed to keep a close eye on a heart device called an EV-ICD. This device is used to treat serious conditions where the heart beats too fast and irregularly, which doctors call ventricular arrhythmia or tachycardia. While the EV-ICD has already been approved for use, this study helps everyone understand how it performs over a long period in real-world situations, outside of initial trials. It's like continuing to check on a new car model after it's sold to make sure it's running perfectly for all drivers.

Medtronic, the company that makes the EV-ICD, is sponsoring this study. They want to confirm that the device remains safe and effective for all patients once it's available and used broadly. This type of study, called a registry, collects information from many different hospitals and clinics around the world where the EV-ICD is being used. This gives researchers a lot of important information to make sure the device continues to meet high standards.

Essentially, this study is about ensuring peace of mind for patients and doctors. It's a way of continuously monitoring the EV-ICD's performance to make sure it's helping people with dangerous heart rhythms live healthier, safer lives. The findings from this study will help improve care for future patients as well.

Key takeaways

It's a study looking at an EV-ICD heart device.
The study checks the device's safety and how well it works.
It's for patients who are getting or already have an EV-ICD.
You won't have extra appointments; information comes from your usual check-ups.
Your participation helps improve care for future patients.
You can stop being part of the study whenever you want to.

Who may be eligible?

To be part of the Enlighten Study, there are a few simple requirements. Firstly, you or a trusted adult who can make decisions for you would need to give written permission to join. This is a standard step for any study and ensures you understand what's involved.

Secondly, you must be a patient who is already planning to get an EV-ICD device, or who will be treated with one. You would need to sign up for the study before your device is put in. This study is open to both men and women of all ages.

However, there are a few reasons someone might not be able to join. If doctors think it would be too difficult to keep in touch with you for your follow-up appointments, you might not be eligible. Also, if you are already part of another medical study that looks at medicines or other devices, you might not be able to join this one, as it could make the results confusing. Your doctor will help you understand if this study is right for you.

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.

I am planning to get, or have already received, an EV-ICD device.
I am able to provide written permission (or a legal representative can).
I am able to attend my usual follow-up appointments.
I am not currently in another medical study for a drug or device that might interfere.

Answer every question to see your result.

What does participation involve?

If you decide to join the Enlighten Study, your main part will be to attend your regular check-up appointments after your EV-ICD device has been put in. These appointments are part of your usual medical care, so you would be going anyway. The study simply collects information from these appointments. You'll need to attend at least one check-up each year, or more often if your doctor thinks it's necessary due to any specific health concerns.

The study will follow you and your device for as long as the device is working, which could be many years, or until the study officially ends. You won't need to take any extra medicines for the study, and your device will function as it normally would. You are always free to leave the study at any time if you change your mind.

Potential risks and benefits

Taking part in this study primarily involves allowing doctors to collect information from your existing medical care. This means there are very few direct risks beyond what you would experience with your normal EV-ICD treatment. The potential benefit is that your information will contribute to a better understanding of how the EV-ICD works in many patients, potentially helping to improve care for others in the future. You always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (131)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cardiology Associates Medical Group
Verified postcode
Huntington Park, United States
Sequoia Hospital
Verified postcode
Redwood City, United States
University of California San Diego
Verified postcode
San Diego, United States
Stanford Hospital & Clinics
Verified postcode
Stanford, United States
Hartford Hospital
Verified postcode
Hartford, United States
Clearwater Cardiovascular Consultants
Verified postcode
Clearwater, United States
Baptist Health
Verified postcode
Jacksonville, United States
Cardiovascular Institute of Northwest Florida
Verified postcode
Panama City, United States
Intercoastal Medical Group
Verified postcode
Sarasota, United States
Wellstar Research Institute
Verified postcode
Marietta, United States
Deaconess Specialty Physicians
Verified postcode
Newburgh, United States
Iowa Heart Center
Verified postcode
West Des Moines, United States

Common questions

What is an EV-ICD?

An EV-ICD is a special heart device designed to treat very fast and dangerous heart rhythms, helping to protect you from serious heart events.

Why is this study being done?

This study is being done to check how safely and effectively the EV-ICD works in patients after it's been approved for general use, in everyday life.

Do I have to do anything special if I join?

No, you don't need to do anything extra. The study will gather information during your regular follow-up appointments for your EV-ICD and device.

How long will I be in the study?

You'll be followed for as long as your EV-ICD device is in place, which means for many years, or until the study officially closes.

Can I leave the study at any time?

Yes, absolutely. You can decide to leave the study at any point, and it won't affect the medical care you receive for your heart.