Cardiac Health Indicators Improve Following CCM Implantation in Heart Failure

A year after implantable cardiac contractility modulation (CCM) therapy, patients exhibited substantial improvements across multiple cardiac health indicators, according to a new post-approval study.1

These data were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 in Phoenix, Arizona, by Rami Kahwash, MD, professor of medicine, cardiology, and director of the Heart & Vascular Research Organization at the Ohio State University Wexner Medical Center.1

“The study is single-arm; we cannot establish causality here because of the design,” Kahwash told HCPLive in an exclusive interview. “But what we did notice is the concordance of all of these clinical outcomes, with all of them improving or heading in the right direction.”

The study itself was a prospective, multi-center, non-randomized, single-arm open-label study of patients receiving Impulse Dynamics’ OPTIMIZER implant and CCM therapy to treat heart failure (HF) symptoms and left ventricular ejection fraction (LVEF) 25-45%. Eligible patients were ≥18 years old and had New York Heart Association (NYHA) Class 3 HF symptoms, among other criteria. Patients with primary HF due to uncorrected mitral valve disease, myocardial infarction within 90 days before implant, and with prior heart transplant or ventricular assist device implantation, among other criteria, were excluded.2

Kahwash and colleagues included 3 primary outcome measures, including the incidence of procedure- and device-related complications at 1 year, all-cause mortality at 3 years, and procedure-related complications at 30 days. The main secondary outcome was the change in cardiovascular hospitalization rates and HF hospitalization rates from 1 year before implantation to 2 years following the operation.2

Enrollment was initiated in February of 2020 and completed in September of 2025 – in this time, 692 patients were enrolled in the study and completed 3-year long-term follow-up. By June 2026, 1-year snapshots had been taken for analysis, with 530 patients ultimately having paired baseline and 1-year data. Among these 530 patients, mean age was 67.3 +/- 10.9 years, mean LVEF was 37.7% +/- 8.2%, and 40.6% had atrial fibrillation (AF). Additionally, 94% of patients were using beta blockers, 56.6% were using ARNIs, 27% were using ACEs or ARBs, and 35.7% were using SGLT2 inhibitors.1

Ultimately, Kahwash and colleagues noted a 34% reduction in HF hospitalization at 1 year post-implant, decreasing from 152 events pre-CCM to 91 after 1 year (-34% change; P = .039). 97% of patients also saw improved or stabilized NYHA class at 1 year, and 68% had improved NYHA class at 1 year. Quality of life was also assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ), highlighting a minimal clinically meaningful improvement of ≥5 points in 70% of patients. NT-proBNP was stable from baseline to 1 year, and Kahwash and colleagues found a predictive association between elevated NT-proBNP – specifically >1000 pg/mL – and long-term mortality.1

The team ultimately determined that, despite the non-randomized study design and lack of a control group, the study still adequately reflected real-world clinical practice and reflected outcomes in the setting of contemporary guideline-directed medical therapy (GDMT). Additionally, Kahwash addressed the trajectory of the study moving forward, as this 1-year data is far from the end of this analysis.1

“We’re excited that this trial is not going to stop at 1 year. We’re following these patients for 3 years, so we’re going to have long-term follow-ups coming in,” Kahwash said. “I think the goal for this analysis in the next few years is to show that all those signals have been in concordance with more of the objective data that we’re going to be analyzing on a yearly basis, such as echocardiographic data and long-term follow-up with NT-proBNP.”

Editors’ Note: Kahwash reports disclosures with Impulse Dynamics, Medtronic, Edwards Lifesciences, VivaLinq, and Boston Scientific.

References

1. Kahwash M, Aziz E, Boo L, et al. One-Year Real-World Clinical Outcomes Following Cardiac Contractility Modulation Therapy from the U.S. Post-Approval Study. Presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026, Phoenix, AZ. October 9-12, 2026.

2. Impulse Dynamics. Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy (PAS). ClinicalTrials.gov Identifier: NCT03970343. Updated November 20, 2025. Accessed November 2, 2026. https://clinicaltrials.gov/study/NCT03970343?term=NCT03970343&rank=1