INVESTIGATORS

About AIM HIGHer

The AIM HIGHer Clinical Trial is a prospective, multicenter, randomized, quadruple-blind, sham-controlled, two-part embedded trial of the safety and efficacy of CCM® therapy delivered by the Optimizer® Smart Mini in subjects with heart failure and an LVEF ≥40% and ≤70%. Subjects will be enrolled at approximately 150 sites in the US.

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 therapy ON (CCM therapy group) or CCM therapy 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 therapy turned ON after completing 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 subjects) 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.

Part I

 

Part I - Primary Efficacy Objectives

  • Change in 6-minute walk distance (6MWD) from baseline to 6 months. The 6MW test is a non-invasive exercise test used to evaluate functional capacity in which the distance walked on a flat surface in a six- minute time period is measured, in accordance with the 6MWT Instructions and Documentation detailed in the study procedures (to be provided separately).

Part I - Primary Safety Objective

  • The change in the health status from baseline to 6 months as assessed by the KCCQ CSS. The KCCQ is a 23-item patient-reported outcome instrument with a total possible score of 0-100; the higher the score indicates better health-related quality of life. The CSS is a 13-item section within KCCQ that includes the domains that measure symptoms (frequency and burden) and physical limitations associated with heart failure. A licensing agreement will be obtained from Outcomes Instruments, LLC prior to study initiation.

Part II 

 

Part II – Primary Objective

The hierarchical composite of cardiovascular-related mortality, heart failure hospitalization, and urgent heart failure visits requiring IV treatment at 18-months and change in KCCQ CSS from baseline at 12-months. The CEC will review, adjudicate and classify all reported deaths, hospitalizations, and urgent health care visits through the 18-month blinded phase of the trial. The CEC will adjudicate each death as attributable to cardiovascular causes or not, will classify each episode of care in the hospital setting as attributable primarily to heart failure or not, and classify urgent health care visits as attributable to heart failure requiring the use of IV therapy or not. In addition, the KCCQ CSS will be assessed as previously described in the Part 1 primary efficacy endpoint.

  • Symptomatic HF
  • LVEF ≥ 40% and ≤ 70% (per site echo)
  • Stable scheduled oral loop diuretic (or spironolactone) treatment ≥30 days OR SGLT2 inhibitor with PRN diuretic (unless documented allergy/intolerance to either or both meds)
  • Must meet ONE of the following five criteria:
  1. HF admission (primary or secondary dx) within 12 months before consent
  2. HF visit requiring IV therapy, outpatient Furoscix, or intensification of oral diuresis within 6 months before consent
  3. PCWP > 15 mmHg up to 6 months prior to consent or within 30 days following consent
  4. IPAP reading of mean pressure ≥ 22 mmHg ≥2 readings within 30 days or consent OR ≥3 readings within 60 days across different days (sensor implanted ≥3 months before first reading)
  5. BNP or NT-proBNP
    Threshold based on cardiac rhythm at baseline EKG (NSR vs. atrial tachyarrhythmia)
NT-proBNP:
NSR: ≥ 150
AT: ≥ 450		 BNP:
NSR: ≥ 50
AT: ≥ 150

 

 

 

 

  • BMI > 46
  • Receiving CRT therapy (Note: subjects w/ active/ongoing CRT implanted > 1yr prior to consent and NYHA class III or higher are eligible for inclusion)
  • Severe valvular stenotic disease or regurgitation
  • Amyloidosis, complex congenital heart defects, eccentric hypertrophic cardiomyopathy
  • Mechanical tricuspid valve
  • Baseline 6MWD < 100m or > 450m
  • Baseline KCCQ CSS > 85
  • MI < 90 days
  • eGFR < 15 or permanent dialysis

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