NCT05064709

Assessment of CCM in HF With Higher Ejection Fraction

Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Impulse Dynamics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 ≥40% and ≤70%.

Detailed description

The AIM HIGHer Clinical Trial is a prospective, 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 ≤70%. Subjects will be enrolled at approximately 150 sites in the US and 75 sites OUS. 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 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.

Conditions

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Heart Failure With Mid Range Ejection Fraction
• Heart Failure With Moderately Reduced Ejection Fraction
• Diastolic Heart Failure

Interventions

Type	Name	Description
DEVICE	Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System	The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed ON for the first 18 months (blinded phase). CCM therapy will be programmed to deliver 7 one-hour phases of CCM therapy that are distributed equally over every 24-hour period. CCM will remain on following completion of the 18-month visit.
DEVICE	OPTIMIZER™ Smart Mini System	The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed OFF for the first 18 months (blinded phase). CCM will be turned on following completion of the 18-month visit.

Timeline

• Start date: 2022-02-03
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2021-10-01
• Last updated: 2026-01-15

Locations

112 sites across 1 country: United States

Regulatory

• FDA-regulated device study