Assessment of CCM in HF With Higher Ejection Fraction

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System — DEVICE
  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.
• OPTIMIZER™ Smart Mini System — DEVICE
  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.

Study Details

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%.

Key Dates

Start date

Feb 3, 2022

Status verified

May 2026

Primary completion

Feb 1, 2029

Completion

Feb 1, 2029

Study Design

Enrollment

1,500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CCM Group (CCM ON)
  CCM therapy will be turned on in 2/3 of the subjects for the entire duration of the study.
• Sham Comparator: Sham Group (CCM OFF)
  CCM therapy will be turned off in 1/3 of the subjects for the first 18 months of the study. After 18 months, CCM therapy will be turned on for the rest of the study duration.

Primary Outcome Measure

Part 1 Efficacy Endpoint - Change in 6-minute walk distance (6MWD) from baseline to 6 months. [ Time Frame: 6 months ]

Central Contacts

• Rachael Riccitello
  856-434-7981
  [email protected]

Locations (105)

Find similar trials in Birmingham, AL

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