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Cardiac Contractility Modulation
CCM Therapy for Heart Failure (AIM HIGHer Trial)
N/A
Recruiting
Led By Javed Butler, MD, MPH, MBA
Research Sponsored by Impulse Dynamics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or non-pregnant female, 21 years or older;
Diagnosed with symptomatic heart failure;
Must not have
Any severe valvular stenotic disease or any severe valvular regurgitation
Complex congenital heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
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%.
Who is the study for?
Adults diagnosed with symptomatic heart failure, who have been hospitalized for it or needed urgent IV therapy in the past year, and have a left ventricular ejection fraction (LVEF) between 40% and 60%. They must be on stable diuretic treatment. Exclusions include pregnancy plans during the study, certain heart rates, complex heart conditions, inability to walk specific distances, recent acute heart issues or procedures.Check my eligibility
What is being tested?
The AIM HIGHer trial is testing the safety and effectiveness of Cardiac Contractility Modulation (CCM) therapy using the OPTIMIZER™ Smart Mini System in patients with moderate levels of heart failure (LVEF ≥40% ≤60%).See study design
What are the potential side effects?
While not specified here, CCM therapy side effects may include discomfort at implant site, infection risk from surgery to place device, potential changes in heartbeat rhythm or interaction with other devices like pacemakers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man or a non-pregnant woman aged 21 or older.
Select...
I have been diagnosed with heart failure that causes symptoms.
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I have been diagnosed with heart failure that causes symptoms.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe heart valve disease.
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I was born with a complex heart condition.
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I can't walk 100 meters but can walk more than 450 meters in a 6-minute walk test.
Select...
My heart-related quality of life score is above 85.
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I have a type of heart disease that thickens, stiffens, or inflames my heart muscle.
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I have not had unstable chest pain in the last 30 days.
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I was treated for severe heart failure with IV or ultrafiltration in the last 30 days.
Select...
I am on permanent dialysis or my kidney function is very low.
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I am currently receiving or have received cancer treatment in the last 2 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 Efficacy Endpoint - Change in 6-minute walk distance (6MWD) from baseline to 6 months.
Part 1 Efficacy Endpoint - Change in the health status from baseline to 6 months as assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS).
Part 1 Safety Endpoint - The incidence of Optimizer device- or procedure-related complications within the first 12 months after implant
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CCM Group (CCM ON)Experimental Treatment1 Intervention
CCM therapy will be turned on in 2/3 of the subjects for the entire duration of the study.
Group II: Sham Group (CCM OFF)Placebo Group1 Intervention
CCM therapy will be turned off in 1/3 of the subjects for the first 18 months of the study. After 18 months, CCM therapy will be turned on for the rest of the study duration.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cardiac Contractility Modulation (CCM) therapy enhances the strength of cardiac muscle contractions without increasing oxygen consumption, which is crucial for improving cardiac output and efficiency in heart failure patients. Other common treatments include beta-blockers, which reduce heart rate and myocardial oxygen demand; ACE inhibitors and ARBs, which lower blood pressure and reduce strain on the heart; and diuretics, which decrease fluid overload and reduce symptoms of congestion.
These therapies collectively aim to improve heart function, reduce symptoms, and enhance quality of life for heart failure patients.
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Who is running the clinical trial?
Impulse DynamicsLead Sponsor
12 Previous Clinical Trials
2,415 Total Patients Enrolled
10 Trials studying Heart Failure
2,015 Patients Enrolled for Heart Failure
Javed Butler, MD, MPH, MBAPrincipal InvestigatorBaylor Scott and White Research Institute, Dallas, Texas
1 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Heart Failure
27 Patients Enrolled for Heart Failure
Oussama Wazni, MD, MBAPrincipal InvestigatorDepartment of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: CCM Group (CCM ON)
- Group 2: Sham Group (CCM OFF)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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