All studies
Active not recruitingNAINTERVENTIONAL

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients

This study is investigating a new and unique medical device called the WiSE-CRT System. It's designed for people living with heart failure, specifically those who haven't found relief from existing treatments or haven't been able to have them for various reasons. The WiSE-CRT System is special because it can pace the heart wirelessly, meaning it doesn't need a wire (lead) to reach the left side of the heart. The main goal of this research is to check if this new wireless pacing system is safe to use and if it can effectively help the heart pump blood better. This could offer a new option for patients who currently have limited choices.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
EBR Systems, Inc.
Enrolment target
300
Start
17 Jan 2018
Estimated completion
01 Jun 2026

What is this study about?

Heart failure is a condition where your heart doesn't pump blood around your body as well as it should. This can make you feel tired, breathless, and limit what you can do. For some people with heart failure, a special type of pacemaker called Cardiac Resynchronization Therapy (CRT) can help the heart's chambers beat together more effectively, improving its pumping action. However, traditional CRT systems use a wire (called a lead) that goes into a vein to reach the left side of your heart.

This study is about a new device called the WiSE-CRT System. What makes it different is that it can pace the left side of the heart without needing a physical wire. Instead, it uses a small, wireless device placed inside the heart to help it beat in a more coordinated way. This could be a really important option for people who haven't been able to benefit from standard CRT because of problems with implanting the wires or if the wires stopped working.

The researchers want to find out if this new wireless system is both safe to use and effective in helping people with heart failure feel better and improve their heart’s function. They are focusing on patients who haven't responded well to current treatments or those who couldn't have the traditional wired system in the first place.

Key takeaways

  • It's a study for adults with heart failure.
  • It's testing a new wireless heart pacing system called WiSE-CRT.
  • It targets patients who haven't responded to or couldn't receive standard treatments.
  • The main goals are to check the system's safety and effectiveness.
  • It offers a potential new option for managing heart failure.
  • Participation involves medical checks and follow-up appointments.

Who may be eligible?

This study is looking for adults aged 18 or over who have had heart failure for some time. You would generally be considered if your heart isn't pumping blood very well (your heart's ejection fraction is 35% or less), and you have specific electrical patterns in your heart (seen on an ECG).

Specifically, the study is for people who have struggled to get or benefit from existing heart pacing treatments. This includes individuals who attempted to have a standard CRT device but couldn't because of difficulties placing the wires, or if their existing CRT wires stopped working properly. It also includes people who might be considered at high risk for upgrading to a traditional wired system.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with heart failure?
  3. Is your heart's pumping ability (ejection fraction) 35% or less?
  4. Have other heart pacing treatments not worked well for you, or were you unable to have them?
  5. Do you have certain electrical patterns in your heart (like LBBB)?
Answer every question to see your result.

What does participation involve?

The detailed description of participation isn't provided in the brief summary. Typically, taking part in a study like this would involve several hospital visits for health checks, device implantation, and follow-up appointments. These appointments would likely include tests such as ECGs (heart tracings), echocardiograms (ultrasound scans of your heart), and blood tests to monitor your heart function and the device’s performance. You would also have regular check-ups to see how you are feeling and if your symptoms have improved. The total duration of participation usually involves follow-up over several months or even years. All aspects of your participation would be clearly explained by the study team, and you would have the chance to ask any questions.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The potential benefit of this study is that the WiSE System might improve your heart's ability to pump blood, which could lead to you feeling better and having fewer symptoms, especially if other treatments haven't worked for you. However, as with any medical procedure or implanted device, there are potential risks, including infection, bleeding, or issues with the device itself. The study team will explain all known risks to you in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (68)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Heart Center Research
    Verified postcode
    Huntsville, United States
  • University of California, San Diego
    Verified postcode
    La Jolla, United States
  • Broward Health Medical Center
    Verified postcode
    Fort Lauderdale, United States
  • St. Vincent's Healthcare
    Verified postcode
    Jacksonville, United States
  • Watson Clinic
    Verified postcode
    Lakeland, United States
  • Naples Community Hospital
    Verified postcode
    Naples, United States
  • Northside Hospital and Heart Institute
    Verified postcode
    St. Petersburg, United States
  • Piedmont Heart Institute
    Verified postcode
    Atlanta, United States
  • Emory Healthcare
    Verified postcode
    Atlanta, United States
  • Prairie Heart
    Verified postcode
    Springfield, United States
  • St. Vincent's Hospital and Healthcare Center
    Verified postcode
    Indianapolis, United States
  • University of Iowa
    Verified postcode
    Iowa City, United States

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as effectively as it should. It can lead to symptoms like tiredness and breathlessness.

What is the WiSE System?

The WiSE System is a new type of heart pacemaker that works wirelessly. It helps coordinate your heart's beating without needing a physical wire to the left side of your heart.

Who is this study for?

This study is for people with heart failure who haven't responded well to other treatments or who couldn't have traditional wired pacing systems due to various reasons.

Is the WiSE System available now?

No, it's currently being studied in a clinical trial to see if it's safe and effective before it can be widely used.

What does 'LBBB' mean?

LBBB stands for Left Bundle Branch Block, which is a specific pattern seen on an ECG that can affect how your heart beats.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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