1500 Participants Needed

CCM Therapy for Heart Failure

(AIM HIGHer Trial)

Recruiting at 80 trial locations
AS
MF
KH
Overseen ByKim Helgeson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Impulse Dynamics
Must be taking: Loop diuretics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests a device that helps the heart pump better in patients with moderate heart failure. It targets those whose heart's pumping ability is moderately reduced. The device works by giving the heart small electrical boosts. Several new devices for the treatment of heart failure patients have been introduced and are increasingly used in medical practice or are under evaluation.

Will I have to stop taking my current medications?

The trial requires that participants stay on a stable dose of oral loop diuretics for at least 30 days before joining. It doesn't specify if you need to stop other medications, so it's best to discuss with the trial team.

What data supports the effectiveness of this treatment for heart failure?

Research shows that Cardiac Contractility Modulation (CCM) therapy, delivered by the Optimizer Smart System, is safe and can improve exercise tolerance and quality of life in heart failure patients. It is especially beneficial for those who do not qualify for other therapies, like cardiac resynchronization therapy (CRT), and has been shown to work without increasing oxygen demand.12345

Is Cardiac Contractility Modulation Therapy safe for humans?

Research indicates that Cardiac Contractility Modulation (CCM) therapy, delivered by the Optimizer Smart System, is generally safe and feasible for a wide range of patients with heart failure.12346

How is Cardiac Contractility Modulation Therapy different from other heart failure treatments?

Cardiac Contractility Modulation (CCM) Therapy, delivered by the Optimizer Smart Mini System, is unique because it uses electrical signals to improve heart function in patients who do not qualify for other device therapies like cardiac resynchronization therapy (CRT). It is specifically designed for heart failure patients with a normal QRS duration and can be used in those who do not respond to CRT, offering a new option for improving heart performance and quality of life.12347

Research Team

OW

Oussama Wazni, MD, MBA

Principal Investigator

Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA

JB

Javed Butler, MD, MPH, MBA

Principal Investigator

Baylor Scott and White Research Institute, Dallas, Texas

Eligibility Criteria

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.

Inclusion 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.
Your NT-proBNP levels are too high, or your BNP levels are too high, especially if you have atrial tachyarrhythmia.
See 11 more

Exclusion Criteria

I can't walk 100 meters but can walk more than 450 meters in a 6-minute walk test.
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.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Testing and Implantation

All eligible subjects will undergo baseline testing and be implanted with the Optimizer System

1-2 weeks
1 visit (in-person)

Treatment Part I

CCM therapy is evaluated for safety and effectiveness based on functional capacity and health status

6 months
Regular visits (in-person)

Treatment Part II

CCM therapy is evaluated for safety and effectiveness based on clinical outcome data

12 months
Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
2 visits (in-person)

Treatment Details

Interventions

  • Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System
  • OPTIMIZER™ Smart Mini System
  • Sham Therapy
Trial OverviewThe 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%).
Participant Groups
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.

Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Optimizer Smart Mini for:
  • Heart failure in NYHA Class III patients with LVEF ranging from 25% to 45%, who remain symptomatic despite guideline directed medical therapy and are not indicated for CRT
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Approved in European Union as Optimizer Smart Mini for:
  • Heart failure in NYHA Class III patients with LVEF ranging from 25% to 45%, who remain symptomatic despite guideline directed medical therapy and are not indicated for CRT

Find a Clinic Near You

Who Is Running the Clinical Trial?

Impulse Dynamics

Lead Sponsor

Trials
14
Recruited
3,800+

Findings from Research

Cardiac contractility modulation (CCM) therapy using the Optimizer Smart System is a new, minimally invasive device therapy for heart failure patients who do not qualify for traditional treatments like cardiac resynchronization therapy (CRT).
Initial findings suggest that CCM therapy is safe and feasible for a broad range of heart failure patients, but further large-scale randomized controlled trials are needed to confirm its effectiveness.
Optimizer Smart System for the treatment of chronic heart failure: Overview of its safety and efficacy.Chera, HH., Al-Sadawi, M., Michelakis, N., et al.[2021]
The Optimizer Smart device, which uses cardiac contractility modulation (CCM), is FDA-approved for treating chronic heart failure in patients with a left ventricular ejection fraction (LVEF) between 25% and 45%, offering a new option for those who are symptomatic despite optimal medical therapy.
Clinical trials show that CCM therapy is safe and effective, leading to reduced hospitalizations for heart failure and improved symptoms, quality of life, and functional performance, particularly for patients who do not qualify for traditional cardiac resynchronization therapy.
Optimizer Smart in the treatment of moderate-to-severe chronic heart failure.Campbell, CM., Kahwash, R., Abraham, WT.[2021]
In a retrospective study of 68 heart failure patients treated with Cardiac Contractility Modulation (CCM), long-term mortality rates were significantly lower than predicted by the Seattle Heart Failure Model, suggesting a potential survival benefit from this treatment.
The study followed patients for an average of 4.5 years, showing that CCM may improve survival outcomes in heart failure patients with NYHA II-III symptoms and a QRS duration of ≤130ms, indicating its efficacy in this specific population.
Long-term survival with Cardiac Contractility Modulation in patients with NYHA II or III symptoms and normal QRS duration.Kloppe, A., Lawo, T., Mijic, D., et al.[2016]

References

Optimizer Smart System for the treatment of chronic heart failure: Overview of its safety and efficacy. [2021]
Optimizer Smart in the treatment of moderate-to-severe chronic heart failure. [2021]
Long-term survival with Cardiac Contractility Modulation in patients with NYHA II or III symptoms and normal QRS duration. [2016]
First use of cardiac contractility modulation (CCM) in a patient failing CRT therapy: clinical and technical aspects of combined therapies. [2011]
[Improving left ventricular contractility by stimulation during the absolute refractory period--cardiac contractility modulation (CCM)]. [2021]
Comparison of left ventricular reverse remodeling induced by cardiac contractility modulation and cardiac resynchronization therapy in heart failure patients with different QRS durations. [2013]
Cardiac Contractility Modulation in Patients with Ischemic versus Non-ischemic Cardiomyopathy: Results from the MAINTAINED Observational Study. [2021]