CCM Therapy for Heart Failure

(AIM HIGHer Trial)

Recruiting in Palo Alto (17 mi)

+79 other locations

Overseen by Oussama Wazni, MD, MBA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Impulse Dynamics

Must be taking: Loop diuretics

Disqualifiers: Dialysis, Cancer treatment, Heart surgery, others

No Placebo Group

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 7}

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.

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.

Trial 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 (Cardiac Contractility Modulation)
• OPTIMIZER™ Smart Mini System (Cardiac Contractility Modulation)
• Sham Therapy (Device)

Trial Overview 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%).

Participant Groups

Group I: CCM Group (CCM ON) Experimental Treatment 1 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 Group 1 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

🇪🇺 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

Research Locations Nearby Select from list below to view details:

Valley Clinical Trials Northridge, CA

St. Louis Heart and Vascular Bridgeton, MO

Ascension Providence Hospital Southfield, MI

Valley Clinical Trials- Northridge Northridge, CA

More Trial Locations

Who Is Running the Clinical Trial?

Impulse Dynamics Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Optimizer Smart System for the treatment of chronic heart failure: Overview of its safety and efficacy. [2021] Introduction: Heart failure (HF) is a major cause of morbidity and mortality throughout the world. Despite the significant progress in the prevention and treatment of HF, mortality rates still remain high. Device therapy for HF includes cardiac resynchronization therapy (CRT) and the use of an implantable cardioverter-defibrillator (ICD). Recently, a new device therapy for the treatment of HF became available, called cardiac contractility modulation (CCM). CCM is a new device therapy for patients with HF who do not qualify for CRT. It is implanted in a minimally invasive manner to improve the patient's morbidity. Optimizer Smart System is a new device that delivers CCM therapy.Areas covered: We review the function of the Optimizer Smart System, the data from the recent clinical trials, and discuss its efficacy and future projections in the treatment for HF.Expert opinion: CCM therapy provided with the Optimizer® Smart System is safe, feasible, and applicable to a wide range of patients with HF. To demonstrate the effectiveness of the Optimizer Smart System's use merits further large multicenter randomized controlled trials.

2. England pubmed.ncbi.nlm.nih.gov

Optimizer Smart in the treatment of moderate-to-severe chronic heart failure. [2021] Cardiac contractility modulation, also referred to as CCM™, by the Optimizer Smart device is an innovative intracardiac device-based therapy that has been recently US FDA-approved for the treatment of patients with chronic heart failure, left ventricular ejection fraction (LVEF) between 25 and 45%, QRS

3. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term survival with Cardiac Contractility Modulation in patients with NYHA II or III symptoms and normal QRS duration. [2016] Cardiac Contractility Modulation (CCM) is a treatment for heart failure based on electrical signals applied during the absolute refractory period. CCM improves myocardial molecular and biochemical characteristics of heart failure and improves exercise tolerance and quality of life. However, the long term impact on survival has not been described.

4. England pubmed.ncbi.nlm.nih.gov

First use of cardiac contractility modulation (CCM) in a patient failing CRT therapy: clinical and technical aspects of combined therapies. [2011] Cardiac contractility modulating (CCM) signals delivered by the OPTIMIZER System are being investigated as a treatment for medically refractory heart failure. Previous chronic studies of CCM have excluded patients with prolonged QRS and a cardiac resynchronization therapy (CRT) device. However, symptoms persist in more than 25% of these CRT patients. CCM may offer a therapeutic option for these non-responders. Here we report the first use of CCM signals in a patient who did not respond to treatment with a CRT-D device. We show that the implantation is technically feasible, that the OPTIMIZER and CRT-D devices can coexist without interference and that acute haemodynamic and clinical improvements can be observed. The results suggest that systematic investigation of CCM treatment in CRT non-responders is warranted.

5. Germany pubmed.ncbi.nlm.nih.gov

[Improving left ventricular contractility by stimulation during the absolute refractory period--cardiac contractility modulation (CCM)]. [2021] Cardiac contractility modulation (CCM) is a treatment option for patients with systolic ventricular dysfunction, independent of QRS duration, moderate to severe systolic heart failure and symptoms despite optimal medical therapy. In contrast to cardiac resynchronization therapy (CRT) which has been an established therapy in patients with wide QRS and ventricular asynchrony, CCM can enhance cardiac contractility in patients independent of QRS duration. Whereas inotropic drugs increase oxygen demand, CCM works without additional myocardial oxygen need and without reference to asynchrony. Non-excitatory signals applied during the absolute refractory period have been shown to enhance the strength of left ventricular contraction in animals and humans with heart failure probably due to normalization of myocardial gene expression. Several multicenter studies have demonstrated safety and efficacy of CCM in patients with medically refractory heart failure. We describe the specific technical aspects and conditions in clinical application of CCM.

6. Netherlands pubmed.ncbi.nlm.nih.gov

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 (CCM) is a new device-based therapy for advanced systolic heart failure with normal QRS duration and therefore not suitable for cardiac resynchronization therapy (CRT). Left ventricular (LV) reverse remodeling was reported in patients treated with CCM or CRT, however, the extent of response was not compared.

7. Netherlands pubmed.ncbi.nlm.nih.gov

Cardiac Contractility Modulation in Patients with Ischemic versus Non-ischemic Cardiomyopathy: Results from the MAINTAINED Observational Study. [2021] Cardiac contractility modulation (CCM) is an FDA-approved device-based therapy for patients with systolic heart failure and normal QRS width who are symptomatic despite optimal drug therapy. The purpose of this study was to compare the long-term therapeutic effects of CCM therapy in patients with ischemic (ICM) versus non-ischemic cardiomyopathy (NICM).