On March 14, 2022, Impulse Dynamics (of which I am the CTO and Executive VP) conducted the first implant of a patient in its AIM HIGHer trial. The goal of the blinded study is to evaluate the performance of CCM Therapy to treat heart failure in a population with high ejection fraction (LVEF between 40% and 60%, inclusive).
According to the press release:
“Patients can have HF with severely reduced, moderately reduced, or even preserved ejection fraction (e.g., EF close to the normal range of 60% or above.) Those patients with severely reduced or moderately reduced EF have therapeutic options, including many classes of pharmaceuticals and device therapies such as CCM. However, HF patients with higher EF (e.g., above 40%) have had few therapeutic options thus far to alleviate their symptoms and treat their disease. The purpose of AIM HIGHer is to assess the potential of CCM to improve performance and reduce cardiovascular morbidity and mortality for these patients.
The Optimizer delivers cardiac contractility modulation therapy — a proprietary technology of Impulse Dynamics — to the heart. Impulse Dynamics has designed CCM therapy to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. This breakthrough device has demonstrated its capability of enhancing the quality of life for HF patients no longer responding adequately to medication meant to manage their symptoms.”
AIM HIGHer is the largest randomized sham-controlled therapeutic cardiac device trial to ever be conducted.