PATIENTS OVERVIEW

What is the AIM HIGHer Clinical Study?

The AIM-HIGHer study is a clinical research study designed to evaluate the safety and effectiveness of a therapy called Cardiac Contractility Modulation (CCM®) in people who have heart failure and ongoing symptoms despite medical treatment. This therapy is being studied to better understand how it may help certain people with heart failure.

Do I Qualify? - Take the Quiz Now

What Is Heart Failure

Heart failure is a condition where the heart does not pump blood as well as it should to meet the body’s needs. People with heart failure may experience:

  • Shortness of breath during daily activities or at rest
  • Fatigue or low energy
  • Swelling in the legs or abdomen
  • Weight gain from fluid retention
  • Dizziness or difficulty concentrating

What is CCM Therapy?

 

If you qualify and are enrolled, you will receive an implanted device that delivers CCM® therapy, which sends electrical signals to the heart muscle during each heartbeat.

The device:

  • is implanted under the skin
  • uses two small wires connected to the heart
  • is rechargeable and designed for long-term use

The study will explain all procedures, risks, and alternatives before you decide to participate

Do I Qualify? - Take the Quiz Now

Eligibility

 

WHO MAY BE ELIGIBLE?

You may be eligible if you:

  • Are 18 years or older
  • Have been diagnosed with heart failure
  • Have ongoing symptoms despite treatment
  • Have an ejection fraction between 40% and 70%; this is an assessment done by your cardiologist (echocardiogram) to evaluate your heart’s ability to pump blood.

Further eligibility is determined through medical testing and review by the study team once you have consented for the study.

WHY CONSIDER PARTICIPATING?

 

You may consider joining because:
  • There are limited treatment options for this type of heart failure
  • You will continue receiving standard medical care from your doctor
  • You may help researchers better understand future treatment options
  • Clinical study participants are closely monitored by specialized heart teams
  • Participation is voluntary, and you may leave the study at any time
  • Early access to new heart failure technology and therapies

WHAT CAN I EXPECT IN THE STUDY?

 

If you take part, participation may include:

Screening tests to see if the study is right for you

Implantation of a small device
(similar to the size of a pacemaker)

Scheduled follow-up visits with
the study team and doctors

Completion of questionnaires about
your health and symptoms

The study includes the first phase lasting 18 months and a follow-up period to continue monitoring up to 5 years.
Do I Qualify? - Take the Quiz Now

Where is the study being conducted?

The AIM HIGHer study is being conducted at up to 150 hospital centers across the USA to enroll up 1,500 patients.

Will I need to pay for this?

The procedure and all related costs may be covered by your insurance. You may have some out of pocket expenses related to your co-pay. Impulse Dynamics may cover a portion of this.

How can I get more info?

Click here to fill out a brief survey. Once the survey is complete, you will be connected with an Impulse Dynamics representative to ask you some additional questions if you qualify for the study. Here’s a preview of these questions (PDF) so that you can gather your responses and come back to the survey if needed.

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