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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;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

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%.

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.

AIM HIGHer Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man or a non-pregnant woman aged 21 or older.
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I have been diagnosed with heart failure that causes symptoms.
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I am 18 years or older and not pregnant.
Select...
I have been diagnosed with heart failure that causes symptoms.
Select...
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.
Select...
I have been on a consistent water pill for at least 30 days, unless I'm allergic.
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My medication dose has been mostly stable for the last month.

AIM HIGHer Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

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 more

AIM HIGHer Trial 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.

Find a Location

Who is running the clinical trial?

Impulse DynamicsLead Sponsor
12 Previous Clinical Trials
2,428 Total Patients Enrolled
10 Trials studying Heart Failure
2,028 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

Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System (Cardiac Contractility Modulation) Clinical Trial Eligibility Overview. Trial Name: NCT05064709 — N/A
Heart Failure Research Study Groups: CCM Group (CCM ON), Sham Group (CCM OFF)
Heart Failure Clinical Trial 2023: Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System Highlights & Side Effects. Trial Name: NCT05064709 — N/A
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System (Cardiac Contractility Modulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05064709 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
Arizona
Other
New York
How old are they?
18 - 65
What site did they apply to?
Baptist Health Lexington
Medical City Fort Worth Hospital
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Looking at clinical trials available for my conditions.
PatientReceived 2+ prior treatments
Recent research and studies
~429 spots leftby Feb 2025