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CCM Therapy for Heart Failure (AIM HIGHer Trial)
AIM HIGHer Trial Summary
This trial will test a new heart failure treatment called Cardiac Contractility Modulation (CCM) therapy. They will test its safety and how well it works in patients with heart failure and a left ventricular ejection fraction (LVEF) between 40 and 60%.
AIM HIGHer Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAIM HIGHer Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AIM HIGHer Trial Design
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Who is running the clinical trial?
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- I am a man or a non-pregnant woman aged 21 or older.I was hospitalized for heart failure or needed urgent IV therapy for it in the past year.I can't walk 100 meters but can walk more than 450 meters in a 6-minute walk test.Your NT-proBNP levels are too high, or your BNP levels are too high, especially if you have atrial tachyarrhythmia.You have trouble exercising because of a health condition other than heart failure, and it makes you feel very short of breath or tired.My heart-related quality of life score is above 85.I have a type of heart disease that thickens, stiffens, or inflames my heart muscle.I have not had unstable chest pain in the last 30 days.I was treated for severe heart failure with IV or ultrafiltration in the last 30 days.You have a device called cardiac resynchronization therapy (CRT).I am scheduled for or have recently had heart surgery or a heart procedure.I have not had a heart attack in the last 90 days.You have had a heart transplant or a ventricular assist device before.I am currently receiving or have received cancer treatment in the last 2 years.You are expected to live for less than 18 months from the time you agree to join the study.Your heart's pumping ability is between 40% and 60%.A. You have been hospitalized for heart failure in the past year or needed urgent IV therapy for heart failure in the past 6 months, and have high natriuretic peptide levels. OR B. If you haven't been hospitalized for heart failure in the past year or needed urgent IV therapy for heart failure in the past 6 months, you must still have high natriuretic peptide levels.I have been on a consistent water pill for at least 30 days, unless I'm allergic.My medication dose has been mostly stable for the last month.Your heart rate at rest is less than 50 or more than 110 beats per minute.I am 18 years or older and not pregnant.I have been diagnosed with heart failure that causes symptoms.You weigh more than what is considered healthy for your height.I have been on a consistent water pill for at least 30 days, unless I'm allergic.I have severe heart valve disease.Your blood pressure when you are not active is lower than 100 or higher than 160 mmHg.I was born with a complex heart condition.You have a mechanical tricuspid valve.I am on permanent dialysis or my kidney function is very low.I have been diagnosed with heart failure that causes symptoms.Your heart's ability to pump blood is between 40% and 60% as measured by an echo test.
- Group 1: CCM Group (CCM ON)
- Group 2: Sham Group (CCM OFF)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are participants still welcome to enroll in this research?
"This clinical investigation is currently seeking enrollees; the trial was initially posted on February 3rd 2022 and underwent its most recent update on November 29th of that same year."
How many sites is this clinical trial being administered at?
"The USC Keck School of Medicine in Los Angeles, Florida Broward Health in Fort Lauderdale, Ohio and AdventHealth Orlando in Orlando Texas are all recruiting participants for the trial. Additionally, there are 53 additional sites that have been selected to receive patients."
How many participants are taking part in this clinical experiment?
"Impulse Dynamics, the study sponsor, will coordinate a total of 1500 participants meeting all inclusion criteria across various sites such as USC Keck School of Medicine in Los Angeles, Florida and Broward Health in Fort Lauderdale."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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