Active not recruitingOBSERVATIONAL

Personalized Therapy Study - Attain Stability Quad Post-Approval Study

This study, called the "Attain Stability Quad Post-Approval Study," is designed to check how effectively a particular part of a heart device, called the Model 4798 Left Ventricular (LV) lead, performs over many years. It focuses on people living with heart failure who have this device. This study is important because it tracks the device in a real-world setting, meaning it’s not just in a lab but with actual patients going about their daily lives. Regulators like the FDA ask for studies like this to make sure devices are safe and work well long after they've been approved for use. Participants will be followed for as long as the study runs.

At a glance

Status

Active not recruiting

Sponsor

Medtronic

Enrolment target

1,092

Start

21 Aug 2017

Estimated completion

01 Jan 2028

Heart Failure

What is this study about?

This study is called the "Personalized Therapy Study - Attain Stability Quad Post-Approval Study." It's looking at a specific part of a heart device called the Model 4798 Left Ventricular (LV) lead, which is used in people with heart failure. Think of a 'lead' as a very thin wire that helps deliver electrical signals to the heart.

The main goal of this study is to see how this particular lead works over a long period, once it's already being used by patients in their daily lives. This is important because while devices are tested before they are approved, it’s good to keep checking on them in a wider group of people for many years. It helps doctors and manufacturers understand its performance and any potential issues that might only show up over time.

This study is also a requirement from official health bodies, like the FDA in the US. They ask for these 'post-approval studies' to make sure that medical devices continue to be safe and effective for patients after they've been made available. So, this study plays a key role in ensuring the quality and safety of this heart device.

Key takeaways

This study tracks the long-term performance of the Model 4798 heart lead.
It helps doctors understand how the device works in real-life situations.
It's an 'observational' study, meaning you won't get new treatments.
Participation involves monitoring your existing device during routine care.
It aims to ensure the device remains safe and effective over time.

Who may be eligible?

To join this study, you would either have (or be planned to have) a specific medical device called a Model 4798 LV lead, along with a Medtronic CRT device. You would also need to be within 30 days of receiving your therapy at the time you were first enrolled in the wider product surveillance system that this study is part of.

Before you can take part, you or your legal representative will need to give written permission. This ensures you understand what the study involves and agree to participate.

There are also some reasons why you might not be able to join. For example, if it's thought that doctors won't be able to keep in touch with you for follow-up appointments, or if you're already in another study (either for a medicine or another device) that might make it hard to understand the results of this one, you wouldn't be able to participate. Also, if local laws have specific rules about who can join, those would also apply.

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.

Do I have, or am I planned to receive, a Model 4798 lead and a Medtronic CRT device?
Was I enrolled in the broader product surveillance system within 30 days of my therapy?
Am I able to attend follow-up appointments reliably?
Am I currently not involved in another medical study for a drug or device?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be followed for the entire duration of the study period. Because this is an 'observational study,' it means that the researchers will mainly be collecting information from your routine medical check-ups and about your device's performance, rather than asking you to do extra tests or take new medications. You won't be given any new treatments specifically for this study. The study looks at how your existing device works in a real-world setting. The specific number and type of visits would depend on your usual care plan, as the study 'observes' what's already happening with your device.

Potential risks and benefits

Taking part in this study means doctors will be closely monitoring your heart device, which could provide reassurance about its function. However, as it's an observational study, it doesn't involve new treatments or procedures, so there are no additional medical risks from the study itself beyond those associated with your existing heart device and its routine care. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (115)

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

Alaska Heart
Verified postcode
Anchorage, United States
Southwest EP
Verified postcode
Chandler, United States
Cardiology Associates of Northeast Arkansas
Verified postcode
Jonesboro, United States
Saint Vincent Heart Clinic Arkansas
Verified postcode
Little Rock, United States
Chula Vista Cardiac Center
Verified postcode
Chula Vista, United States
San Diego Arrhythmia Associates
Verified postcode
San Diego, United States
COR Healthcare
Verified postcode
Torrance, United States
Cardiovascular Consultants Medical Group (Van Nuys)
Verified postcode
Van Nuys, United States
Cardiology Associates Medical Group
Verified postcode
Ventura, United States
Colorado Springs Cardiology
Verified postcode
Colorado Springs, United States
Denver Heart
Verified postcode
Denver, United States
Colorado Heart and Vascular
Verified postcode
Lakewood, United States

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as well as it should. It doesn't mean your heart has stopped, but it might struggle to keep up with your body's needs.

What is the Model 4798 LV lead?

It's a specific thin wire, or 'lead,' that is part of a heart device. It's designed to help improve pacing for people with heart failure.

Is this a new treatment?

No, this study isn't testing a new treatment. It's looking at how a device that's already approved performs in people's everyday lives over a long time.

How long will I be in the study?

If you join, you will be followed for as long as the study runs. The exact total duration isn't specified, but it's designed to look at long-term performance.

Will I have extra doctor visits?

This is an observational study, so it will mainly gather information from your existing medical care. It's not expected to add many extra visits beyond your routine check-ups for your heart condition and device.