Active not recruitingNAINTERVENTIONAL

Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing

This study is looking at a new treatment called the Modular Cardiac Rhythm Management (mCRM) Therapy System. It's designed for people who have very fast or irregular heartbeats, often called ventricular arrhythmia or tachycardia. The system uses two devices that work together to help control these heart rhythms. One device is a pacemaker that can deliver small electrical pulses to correct fast rhythms, and the other is a special type of defibrillator placed just under the skin. The main goal of this study is to check if this combined system is safe, performs correctly, and is effective in helping patients. Participants will be monitored closely for at least six months after receiving the device.

At a glance

Status

Active not recruiting

Phase

Sponsor

Boston Scientific Corporation

Enrolment target

297

Start

20 Jul 2021

Estimated completion

31 Dec 2030

Tachycardia, Ventricular Arrhythmia, Ventricular

Results

Results from this study

Posted June 2025

Results have been published for this study.

Primary outcome

Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months

Major EMPOWER MPS System- and Procedure-related Complication-Free Rate Subjects will be assessed for safety issues related to the procedure or system through 6 months post implant

Full results on the registry

What is this study about?

This research study, called MODULAR ATP, is investigating a new way to help people who have certain heart rhythm problems, specifically when their heart beats too fast or irregularly from its lower chambers (ventricular tachycardia or arrhythmia). If you've been told you have these conditions, you know how serious they can be.

The new approach being tested is called the Modular Cardiac Rhythm Management (mCRM) Therapy System. Think of it as a team of two devices working together. One part is similar to a pacemaker, which can deliver tiny electrical pulses called 'antitachycardia pacing' to gently stop a fast heartbeat. The other part is a special kind of defibrillator, called an S-ICD, which sits just under the skin (not inside the heart itself) and can deliver a bigger shock if needed to reset a dangerously fast rhythm. The main purpose of this study is to see if these two devices are safe, work well together, and are effective in managing your heart rhythm.

This study is important because it's looking for better ways to manage these serious heart conditions. By joining, you'd be helping doctors understand if this new system could offer a good treatment option for more people in the future. The researchers will be carefully checking how the system performs in real-world conditions.

Key takeaways

Tests a new combined heart rhythm system for faster heartbeats.
Aims to check if two devices (pacemaker and S-ICD) work safely together.
Designed for people with specific fast or irregular heart rhythms.
Requires an implant procedure and at least 6 months of follow-up.
Participation is voluntary; you can withdraw at any time.

Who may be eligible?

To be considered for this study, you generally need to be an adult, either aged 18 or older, and able to understand and sign the consent forms yourself. You would typically already need a reason to have an implantable defibrillator (ICD), based on established medical guidelines, or you might already have a specific type of defibrillator called an S-ICD.

The study is particularly looking for people who are at risk of a specific type of fast heartbeat called monomorphic ventricular tachycardia (MVT). This might include you if you've had certain types of irregular heartbeats before, especially if your heart's pumping ability is reduced (measured by something called LVEF) or you have significant scarring on your heart. It also includes people who have fainted because of an irregular heartbeat, or have certain types of heart weakness (cardiomyopathy).

There are also some reasons why you might not be able to join. For example, if you currently have an infection related to a heart device, or if you need a specific type of pacemaker (dual-chamber or CRT), or a pacemaker that changes its pacing rate based on your activity. If you've recently had a heart attack, have certain blood clots, or are completely dependent on a pacemaker to keep your heart beating, you would likely not be eligible.

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.

Are you 18 years old or older?
Do you have a reason specified by your doctor for an implantable defibrillator?
Are you at risk for certain fast heartbeats (MVT)?
Are you able to agree to take part and attend study appointments?
Do you NOT have an active heart device infection?
Do you NOT need a dual-chamber pacemaker or CRT device?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have the mCRM Therapy System implanted. This involves a small operation to place the devices. After the implantation, you will have regular check-ups with the study team. These check-ups will usually involve monitoring your device and checking your overall health. The researchers will follow you for at least six months after the system is put in. This period allows them to gather important information about how the system is working and whether it's effective for you. You won't be given any new medications specifically for the study, but your existing medical care will continue as usual.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is that the new mCRM Therapy System might better manage your heart rhythm, potentially reducing episodes of fast heartbeats. However, as with any medical procedure involving device implantation, there are potential risks, such as infection, bleeding, or issues with the device itself. The study team will explain all known risks to you in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (38)

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

Banner University Medical Center Phoenix
Verified postcode
Phoenix, United States
Scottsdale Healthcare - Shea
Verified postcode
Scottsdale, United States
Arrhythmia Research Group
Verified postcode
Jonesboro, United States
AdventHealth Orlando
Verified postcode
Orlando, United States
Emory University Hospital
Verified postcode
Atlanta, United States
Baptist Health Lexington
Verified postcode
Lexington, United States
Mayo Clinic
Verified postcode
Rochester, United States
Cooper Hospital - University Medical Center
Verified postcode
Camden, United States
Northwell University Hospital
Verified postcode
Manhasset, United States
Mount Sinai Medical Center
Verified postcode
New York, United States
Cleveland Clinic
Verified postcode
Cleveland, United States
Ohio State University Medical Center
Verified postcode
Columbus, United States

Common questions

What is an S-ICD?

An S-ICD is a defibrillator that is placed under the skin, usually on the side of your chest, rather than inside your heart.

What does 'antitachycardia pacing' mean?

This is when the device delivers small, rapid electrical pulses to try and gently stop a fast heart rhythm and bring it back to normal, without needing a larger shock.

What is LVEF?

LVEF stands for Left Ventricular Ejection Fraction. It's a measurement that tells doctors how well the main pumping chamber of your heart is working.

Will I have to pay to be in the study?

No, you will not have to pay for the study visits or the study device. All study-related care is covered.

What if I change my mind during the study?

You can leave the study at any time, for any reason, and it will not affect your medical care.