Active not recruitingOBSERVATIONAL

Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)

Medtronic is running a study called the iATP PAS. It's designed to check how safe and effective a special kind of heart therapy, called Intrinsic Antitachycardia Pacing (iATP), is in people's everyday lives. This therapy is used to treat a fast and abnormal heart rhythm called ventricular tachycardia. The study is for patients who already have pacemakers or similar devices that can use iATP. It aims to confirm that these devices work as expected after they've been made widely available. Information will be collected regularly, often through remote monitoring, to see how patients and their devices are doing over approximately five years.

At a glance

Status

Active not recruiting

Sponsor

Medtronic

Enrolment target

2,200

Start

01 Aug 2020

Estimated completion

31 Jan 2028

Ventricular Tachycardia

What is this study about?

Imagine your heart sometimes beats too fast and in a disorganised way—this is called ventricular tachycardia. A special kind of device, like a modern pacemaker or defibrillator, can help by giving tiny, quick electrical pulses to correct this rhythm. This study, called the iATP PAS, is looking at a specific feature of these devices called Intrinsic Antitachycardia Pacing (iATP).

Medtronic, the company that makes these devices, wants to make sure this iATP feature is safe and effective for people who use it in their daily lives, after the devices have been released for general use. They want more information on how well it works and if there are any problems when used by many different patients. This is not a study where you are given a new, experimental treatment; instead, it observes people who are already using or are going to use these devices as part of their regular care.

This study will follow how patients and their devices are doing over time. It's a way for doctors and device manufacturers to gather important real-world information, which helps them understand the treatment better and continue to improve heart care for everyone.

Key takeaways

This study observes an existing heart device feature, not a new treatment.
It checks how safe and effective iATP therapy is for fast heart rhythms.
Participation involves ongoing monitoring of your device, often remotely.
The study helps improve future care for people with similar heart conditions.
You can choose to stop participating at any time.

Who may be eligible?

To be part of this study, you would typically need to be someone who is going to receive, or already has, one of these special heart devices that can use the iATP feature. This feature must be switched on to help with your fast heart rhythms. Your device must also be set up to send information remotely (like from your home) to a system called CareLink, which helps doctors monitor your device.

Before joining, you or a legal guardian would need to give written permission. It's important that you're able to keep up with follow-up appointments and monitoring, as the study needs to collect regular information from you.

There are a few reasons why you might not be able to join. For example, if you're already in another study about drugs or devices that could affect the results of this one, or if there's a reason doctors think you wouldn't be able to stay in touch for the full study period.

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 a device that uses iATP, or am I getting one?
Is my iATP feature switched on for my fast heart rhythms?
Can my device send information remotely (e.g., via CareLink)?
Am I able to attend follow-up appointments when needed?
Am I willing to give written permission to take part?

Answer every question to see your result.

What does participation involve?

If you join this study, your journey will be straightforward as it mostly tracks what happens during your usual medical care. You won't be given new medications or experimental treatments. The main part of your participation involves regular check-ups on your heart device. This will typically happen at least once a year, and possibly more often if there are any reported issues or if your device sends important updates.

A key part of the study is that your heart device will regularly send information about its working to your care team, often from your home through a remote monitoring system called CareLink. This usually happens about every three months. The study will continue for roughly five years, or until you decide to stop participating, or leave the study for other reasons.

Potential risks and benefits

The main benefit of taking part in this study is contributing to valuable knowledge about the safety and effectiveness of a common heart device feature. This helps doctors and manufacturers better understand and improve treatment for fast heart rhythms in the future. As this is an observational study of a device already approved for use, there are no expected additional medical risks directly from participating in the study itself beyond those associated with your device and condition. You can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (92)

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

Southwest EP
Verified postcode
Chandler, United States
Saint Vincent Heart Clinic Arkansas
Verified postcode
Little Rock, United States
Chula Vista Cardiac Center
Verified postcode
Chula Vista, United States
Cardiovascular Consultants Medical Group (Van Nuys CA)
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, PC
Verified postcode
Lakewood, United States
Hartford Hospital
Verified postcode
Hartford, United States
Yale New Haven Hospital
Verified postcode
New Haven, United States
Heart Rhythm Solutions
Verified postcode
Hollywood, United States
Baptist Health
Verified postcode
Jacksonville, United States

Common questions

What is Intrinsic Antitachycardia Pacing (iATP)?

It's a special feature in some heart devices that delivers gentle electrical pulses to correct a fast, abnormal heart rhythm (ventricular tachycardia).

Is this a study for a new treatment?

No, this study is about observing how an already approved device feature (iATP) works in real-world patients after it's been made available.

How long will the study last?

The study is expected to last for about five years in total.

Will I need extra doctor visits for this study?

You will have at least annual check-ups, but much of the monitoring of your device happens remotely, usually every three months, so typically no extra visits are needed just for the study.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time without it affecting your medical care.