Active not recruitingOBSERVATIONAL

WiCS-LV Post Market Surveillance Registry

This study is about a new way to pace the heart called the WiCS-LV system. It’s for people with heart failure who might need a special type of pacemaker called Cardiac Resynchronization Therapy (CRT). Unlike standard CRT, this system paces the heart's left side without using a wire (or lead) that goes into the heart's vein. Doctors want to see how this system works for patients over five years in normal hospital settings. They'll collect information from everyone who gets the WiCS-LV system to understand its benefits and how well it helps patients. This is important for those who haven't been able to have standard CRT or haven't improved with it, giving them another potential treatment choice.

At a glance

Status

Active not recruiting

Sponsor

EBR Systems, Inc.

Enrolment target

100

Start

08 Feb 2016

Estimated completion

01 Jun 2027

Cardiac Resynchronization Therapy

What is this study about?

This study is looking at a new heart device called the WiCS-LV system. If you have heart failure, your heart might not pump blood as efficiently as it should. Cardiac Resynchronization Therapy (CRT) is a type of pacemaker that helps the heart's different chambers beat in a more organised way, improving its pumping action. The WiCS-LV system is a new approach to CRT, specifically designed to pace the left side of your heart without needing a wire (called a lead) to be placed inside a vein, which is how traditional CRT works. This could be helpful for people who have problems with the traditional wires.

The main goal of this study is to see how well the WiCS-LV system works in everyday medical care. It's like watching how a new car performs once it's out on the road with real drivers. Doctors will collect information from patients who receive this system over an extended period. This helps them understand its long-term benefits, any potential issues, and how it helps people's heart failure symptoms improve.

By carefully collecting this information from many patients over five years, doctors can learn more about this innovative treatment. This knowledge is important for guiding future patient care, especially for people whose hearts haven't responded well to other treatments or who couldn't have standard CRT due to certain difficulties. It helps ensure that new treatments are safe and effective for those who need them most.

Key takeaways

This study evaluates a new leadless (wire-free) heart pacing system for heart failure.
It's designed for patients unable to receive or benefit from standard CRT.
Information is collected over five years during normal clinical follow-ups.
Participation involves routine monitoring of the device and your health.
The goal is to understand how the WiCS-LV system performs in the real world.

Who may be eligible?

This study is looking for adults (18 years or older) with heart failure who need a special type of pacemaker called Cardiac Resynchronization Therapy (CRT). You might be eligible if you meet the standard guidelines for CRT for heart failure, and you fall into one of these groups.

Firstly, if you've tried to have a standard CRT device fitted but it didn't work out due to problems with placing the wire, or if you had a wire fitted but it's not working properly or causing discomfort. Secondly, you might be eligible if you already have a CRT device but your heart failure symptoms haven't improved after at least 6 months of treatment. Finally, if you need an upgrade to your current pacing device but there are difficulties or risks associated with fitting a standard CRT wire or reopening the device pocket for surgery, this study might be for you.

However, this study isn't suitable if you are taking specific combinations of blood thinners (like warfarin, clopidogrel, and aspirin together), or if you have severe kidney problems (Stage 4 or 5), a serious heart valve problem called Grade 4 mitral valve regurgitation, or very low platelet count.

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 heart failure and meet standard guidelines for CRT?
Have I had problems with, or not responded to, conventional CRT?
Am I 18 years old or older?
Am I not on particular combinations of blood thinners, and don't have severe kidney disease or certain heart valve issues?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the WiCS-LV system as part of your normal medical care. Doctors and nurses will then keep track of your health and how the device is working over the next five years. This means you’ll have regular check-ups at the hospital or clinic, just like you would with any other pacemaker. These check-ups will usually happen about a week after the device is put in, then after 3 months, 6 months, and then once a year for the next five years. At these appointments, medical staff will collect information about your health and the device's performance. You won't be asked to take any new medications for the study itself, as it's about watching how the device works in real life.

Potential risks and benefits

Taking part in this study means you'd receive the WiCS-LV system, which could offer an alternative treatment for your heart failure, particularly if standard treatments haven't worked or weren't suitable. While the aim is to improve your heart health, as with any medical procedure or device, there are always potential risks, such as those related to the implantation surgery or how your body reacts to the device. These will be fully explained by your doctor. You are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (3)

Aalborg University Hospital
Verified postcode
Aalborg, Denmark
Herzzentrum Brandenburg
Verified postcode
Bernau, Germany
Cardiocentro Ticini
Verified postcode
Lugano, Switzerland

Common questions

What is the WiCS-LV system?

It's a new heart pacing system for heart failure that paces the left side of your heart without needing a traditional heart wire (lead) inside a vein.

Who is this study for?

It's for adults with heart failure who need a special pacemaker, especially if standard treatments haven't worked or aren't an option.

How long will I be involved if I join?

You'll be followed by the medical team for five years after the WiCS-LV system is implanted.

What kind of information will be collected?',

Doctors will collect information about your health and how well the device is working during your routine check-ups.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, and it won't affect your ongoing medical care.