Assessment of CCM in HF With Higher Ejection Fraction (NCT05064709) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of CCM in HF With Higher Ejection Fraction
United States1,500 participantsStarted 2022-02-03
Plain-language 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 ā„40% and ā¤70%.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Signed and dated informed consent form;
ā. Male or non-pregnant female, 18 years or older;
ā. Diagnosed with symptomatic heart failure;
ā. LVEF ā„40 and ā¤70% (as assessed by site echo);
ā. 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)
ā. Subjects must meet one of the following conditions:
Exclusion criteria
ā. Resting ventricular rate \<50 or \>110 bpm;
ā. Resting systolic blood pressure \<100 or ā„160 mmHg;
ā. BMI greater than 46
ā. Any severe valvular stenotic disease or any severe valvular regurgitation;
ā. Mechanical tricuspid valve;
ā. Complex congenital heart disease;
ā. 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;
What they're measuring
1
Part 1 Efficacy Endpoint - Change in 6-minute walk distance (6MWD) from baseline to 6 months.
Timeframe: 6 months
2
Part 1 Efficacy Endpoint - Change in the health status from baseline to 6 months as assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS).
Timeframe: 6 months
3
Part 1 Safety Endpoint - The incidence of Optimizer device- or procedure-related complications within the first 12 months after implant
Timeframe: 12 months
4
Part 2 Endpoint - The hierarchical composite of mortality, morbidity, and health status outcomes (KCCQ CSS).