About AIM HIGHer
The AIM HIGHer Clinical Trial objective is to evaluate the safety and efficacy of cardiac contractility modulation therapy in patients with symptomatic heart failure (HF) with an ejection fraction (EF) of 40% – 60% (inclusive). This is a multicenter, randomized, blinded, sham-controlled, IDE clinical trial. There will be approximately 150 study centers in the United States, including up to 1500 subject volunteers.
What Is Heart Failure
Heart failure is a condition in which the heart cannot pump enough blood to meet the body’s needs. Heart failure symptoms may include the following:
- Shortness of breath (SOB) doing everyday activities
- SOB during rest or while lying flat
- Fatigue and tiredness
- Dizziness, confusion, sadness, or depression
- Swelling in lower extremities
- Weight gain
- Abdominal discomfort or swelling
- Little or no appetite
There are currently no device treatment options (and very few overall options) for this kind of heart failure.
You can still receive all the traditional therapy you would have from your doctor in addition to being in the trial.
Patients in clinical trials have historically done better than their non-study counterparts.
Are You Eligible for the Study?
Are you 21 years or older?
Do you have symptomatic HF?
Is your EF 40% to 60%
If you are enrolled, you will receive the Optimizer® CCM® therapy delivery system, which includes the Optimizer Smart Mini implantable pulse generator (IPG) that generates CCM therapy signals across two electric wires (leads) that will connect your heart to the IPG and deliver CCM therapy. You will also be provided with an IPG charger. The implanted device is programmed to deliver seven one-hour phases of therapy every 24 hours. The rechargeable battery in the IPG can keep working for 20 years or more without needing to be replaced.
Duration of Participation and Randomization
(1) Screening and baseline evaluation period — this will take approximately one month.
(2) Blinded study period — this will take 18 months.
a. Optimizer Smart Mini implantation procedure: If baseline testing shows that you qualify to participate in this study, you will undergo implantation of the Optimizer Smart Mini.
b. Randomization: You will then be randomly placed into one of two groups, like drawing straws. Neither you nor your doctor will know to which group you have been assigned.
i. ACTIVE GROUP: You will have a 2/3 chance of having CCM therapy turned ON.
ii. SHAM GROUP: You will have a 1/3 chance of having CCM therapy turned OFF.
(3) Long-term, unblinded follow-up period — this could last more than five years. After the 18-month blinded phase of the trial is completed, you will begin the unblinded phase of the trial. If you are in the SHAM group with CCM therapy OFF, you will have CCM therapy turned ON at this time, so all devices will have CCM therapy turned ON after the blinded phase. A long-term follow-up period is required to continue to monitor your device and safety events. During the same time, enrollment and follow-up are intended to be completed for all subjects while FDA decides the safety and efficacy of CCM therapy in patients with HF(40-60)pEF. This long-term follow-up period could last more than five years, depending on when you are enrolled.