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Evaluating Cardiac Contractility Modulation in Heart Failure Patients

Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction

NA · Impulse Dynamics · NCT05064709

This study is testing a new heart treatment called Cardiac Contractility Modulation to see if it can help people with heart failure feel better and improve their heart function.

Quick facts

PhaseNA
Study typeInterventional
Enrollment1500 (estimated)
Ages18 Years and up
SexAll
SponsorImpulse Dynamics (industry)
Drugs / interventionschemotherapy, radiation
Locations105 sites (Birmingham, Alabama and 104 other locations)
Trial IDNCT05064709 on ClinicalTrials.gov

What this trial studies

The AIM HIGHer Clinical Trial aims to assess the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure who have a left ventricular ejection fraction (LVEF) between 40% and 70%. This multi-center, randomized, quadruple-blind, sham-controlled trial will involve approximately 150 sites in the US and 75 sites internationally. Participants will be implanted with the OPTIMIZER Smart Mini System and randomized to receive either active CCM therapy or a sham treatment for 18 months, followed by additional follow-up. The trial is designed to evaluate both functional capacity and clinical outcomes related to heart failure.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with symptomatic heart failure and an LVEF between 40% and 70%.

Not a fit: Patients with heart failure who do not meet the LVEF criteria or have not experienced recent heart failure hospitalizations may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could improve heart function and quality of life for patients with heart failure.

How similar studies have performed: Previous studies on cardiac contractility modulation have shown promise, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Signed and dated informed consent form;
2. Male or non-pregnant female, 18 years or older;
3. Diagnosed with symptomatic heart failure;
4. LVEF ≥40 and ≤70% (as assessed by site echo);
5. A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent OR B. If there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, an elevated BMI-adjusted natriuretic peptide value must be achieved (Refer to Table 1 in Section 9.2.6)
6. Subjects must meet one of the following conditions:

   * Have stable, scheduled oral loop diuretic treatment (not just PRN) for a minimum of 30 days before providing study consent unless there is a documented allergy or intolerance.
   * Eligibility for enrollment is maintained for patients on an SGLT2 inhibitor without prescribed concurrent standing loop diuretic therapy if investigators provide instructions for a flexible PRN diuretic regimen (deemed appropriate by the clinician in response to symptoms or weight gain) Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days. A one-time hold of diuretic dosing for 24 hours during the 30-day period is allowed and not an exclusionary event.

Exclusion Criteria:

1. Resting ventricular rate \<50 or \>110 bpm;
2. Resting systolic blood pressure \<100 or ≥160 mmHg;
3. BMI greater than 46
4. Any severe valvular stenotic disease or any severe valvular regurgitation;
5. Mechanical tricuspid valve;
6. Complex congenital heart disease;
7. Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and/or exercise intolerance;
8. Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
9. A KCCQ CCS score higher than 85;
10. Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy;
11. Unstable angina pectoris within 30 days prior to study consent;
12. Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting;
13. Receiving cardiac resynchronization therapy (CRT); NOTE: Subjects with active/ongoing cardiac resynchronization therapy (CRT) implanted more than one year ago are eligible for inclusion if they are currently classified as NYHA class III or higher.
14. Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
15. Myocardial infarction within 90 days prior to study consent;
16. Prior heart transplant or ventricular assist device;
17. Planning to become pregnant during the study;
18. Dialysis (permanent) or GFR \<15 ml/min/1.73m2;
19. Participating in another investigational drug or device study that may interfere with the interpretation of study data;
20. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent;
21. Expected lifespan of less than 18 months from time of study consent;
22. Unable to follow through study protocol for any reasons in the investigator's judgement.

Where this trial is running

Birmingham, Alabama and 104 other locations

+55 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Heart Failure With Moderately Reduced Ejection Fraction, Diastolic Heart Failure, HFpEF, Heart failure, CCM

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.