Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤60%.

Official Title

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

Details

The AIM HIGHer Clinical Trial is a prospective, multi-center, randomized, quadruple-blind, sham-controlled, two-part embedded trial of the safety and efficacy of CCM therapy delivered via the OPTIMIZER Smart Mini System in subjects with heart failure and an LVEF ≥40% and ≤60%. Subjects will be enrolled at approximately 150 sites in the US and 75 sites OUS.

All subjects will undergo screening and baseline testing; all eligible subjects will be implanted with the Optimizer System. Subjects will be randomized in a 2:1 ratio to either CCM ON (CCM group) or to CCM OFF (Sham group). The trial will be blinded to the treatment assignment of the device for 18-months. Subjects in the Sham group will have CCM turned ON after completion of the 18-month study visit. Subjects enrolled during Part I (450 subjects) of the trial will continue follow-up through the end of Part II (up to an additional 1,050) and contribute data to both parts of the trial. Each part of the trial is distinguished by a separate scientific purpose. The specific purpose of each part is:

Part I - Establish safety and effectiveness based on functional capacity and health status.

Part II - Establish safety and effectiveness based on clinical outcome data.

Keywords

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, CCM, CCM therapy, cardiac contractility modulation, symptomatic heart failure, left ventricular ejection fraction, LVEF, Optimizer, Optimizer Smart Mini, Quality of Life, Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System, OPTIMIZER™ Smart Mini System

Eligibility

You can join if…

Open to people ages 18 years and up

  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 ≤60% (as assessed by echo core lab);
    1. 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, AND elevated BMI-adjusted natriuretic peptide values (Refer to Table A in Section 9.2.6) 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 B in Section 9.2.6)
  5. Subjects must be on stable, scheduled oral loop diuretic treatment (not only PRN) for at least 30 days prior to study consent, unless documented allergy/intolerance.

    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.

You CAN'T join if...

  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); 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 <20 ml/min/1.73m2; 19. Participating in another investigational study; 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;

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Sequoia Hospital accepting new patients
    Redwood City California 94062 United States
  • John Muir Health accepting new patients
    Concord California 94520 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Impulse Dynamics
ID
NCT05064709
Study Type
Interventional
Participants
Expecting 1500 study participants
Last Updated