Health Trials

About this trial

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%.

Eligibility criteria

Qualifiers

Signed and dated informed consent form;

Male or non-pregnant female, 18 years or older;

Diagnosed with symptomatic heart failure;

LVEF ≥40 and ≤70% (as assessed by site echo);

Disqualifiers

Resting ventricular rate <50 or >110 bpm;

Resting systolic blood pressure <100 or ≥160 mmHg;

BMI greater than 46

Any severe valvular stenotic disease or any severe valvular regurgitation;

Trial design

Treatments tested in this trial

  • Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System
  • OPTIMIZER™ Smart Mini System

Treatment groups

1,500 Participants
are divided into 2 treatment groups

Locations

105
Alabama
Grandview Medical Group Research, LLC35243, Birmingham United States
Arizona
CardioVascular Associates of Mesa85206, Mesa United States
Chan Heart Rhythm Institute85206, Mesa United States
Southwest Cardiovascular Associates85208, Mesa United States

Sponsors and collaborators

Impulse Dynamics

Lead sponsor

Source ClinicalTrials.gov