RecruitingHeart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection Fraction

Assessment of CCM in HF With Higher Ejection Fraction

Eligible age

18+ yrs

Accepts

All genders

Locations

31 states

Healthy volunteers

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About this study

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 ≤70%.

Sponsor: Impulse Dynamics

You may qualify if…

✓ 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.

You may not qualify 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;