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Clinical Trial Summary

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

Clinical Trial Description

The AIM HIGHer Clinical Trial is a prospective, multi-national, 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; eligible subjects will be implanted with the Optimizer System. Subjects will be randomized 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. ;

Study Design

Related Conditions & MeSH terms

  • Heart Failure
  • Heart Failure With Mid Range Ejection Fraction
  • Heart Failure With Preserved Ejection Fraction

NCT number NCT05064709
Study type Interventional
Source Impulse Dynamics
Contact Maria Fernanda Villarreal, MD
Phone 8453592389
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 1, 2022
Completion date February 1, 2026

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