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Updated: Feb 27, 2026
Evaluation of Cardiac Contractility Modulation Therapy in 2D Human Stem Cell-Derived Cardiomyocytes
Published on: December 16, 2022
Clinical effects of long-term cardiac contractility modulation (CCM) in subjects with heart failure caused by left
D Müller1, A Remppis2, P Schauerte3
1Heart and Vascular Center (HGZ), Bad Bevensen, Germany.
Insights
Cardiac contractility modulation (CCM) offers long-term symptomatic and functional benefits for heart failure patients. This 2-year study shows CCM is safe and effective, regardless of baseline ejection fraction.
Area of Science:
- Cardiology
- Medical Devices
- Heart Failure Management
Background:
- Heart failure remains a global health challenge with significant morbidity and mortality.
- Guideline-directed medical therapy improves outcomes but leaves many patients symptomatic.
- Cardiac contractility modulation (CCM) shows promise for symptom improvement, but long-term data is limited.
Purpose of the Study:
- To evaluate the 2-year safety and efficacy of CCM in patients with heart failure.
- To assess long-term improvements in heart failure symptoms and function with CCM.
- To analyze CCM outcomes stratified by baseline left ventricular ejection fraction (LVEF).
Main Methods:
- A 2-year, multi-site clinical registry of 143 heart failure patients with reduced ejection fraction.
- Data collection included NYHA class, MLWHFQ score, 6-minute walk distance, LVEF, and peak VO2 at baseline and 6-month intervals.
- Serious adverse events, all-cause mortality, and cardiovascular mortality were recorded and analyzed.
Main Results:
- 106 subjects completed 24-month follow-up; NYHA class and MLWHFQ scores improved across all LVEF groups.
- Left ventricular ejection fraction (LVEF) improved significantly over 24 months.
- Serious adverse events were comparable to other heart failure device trials; 2-year overall survival was 86.4%.
Conclusions:
- CCM provides safe and effective long-term symptomatic and functional improvement in heart failure patients.
- Benefits of CCM were observed independently of baseline LVEF.
- The safety profile of CCM is consistent with established device trials for heart failure.
Introduction:
Heart failure is a major cause of morbidity and mortality throughout the world. Despite advances in therapy, nearly half of patients receiving guideline-directed medical therapy remain limited by symptoms. Cardiac contractility modulation (CCM) can improve symptoms in this population, but efficacy and safety in prospective studies has been limited to 12 months of follow-up. We report on the first 2 year multi-site evaluation of CCM in patients with heart failure.
Methods:
One hundred and forty-three subjects with heart failure and reduced ejection fraction were followed via clinical registry for 24 months recording NYHA class, MLWHFQ score, 6 min walk distance, LVEF, and peak VO2 at baseline and 6 month intervals as clinically indicated. Serious adverse events, and all cause as well as cardiovascular mortality were recorded. Data are presented stratified by LVEF (all subjects, LVEF <35%, LVEF ≥35%).
Results:
One hundred and six subjects from 24 sites completed the 24 month follow-up. Baseline parameters were similar among LVEF groups. NYHA and MLWHFQ improved in all 3 groups at each time point. LVEF in the entire cohort improved 2.5, 2.9, 5.0, and 4.9% at 6, 12, 18, and 24 months, respectively. Insufficient numbers of subjects had follow-up data for 6 min walk or peak VO2 assessment, precluding comparative analysis. Serious adverse events (n = 193) were observed in 91 subjects and similarly distributed between groups with LVEF <35% and LVEF ≥35%, and similar to other device trials for heart failure. Eighteen deaths (7 cardiovascularly related) over 2 years. Overall survival at 2 years was 86.4% (95% confidence intervals: 79.3, 91.2%).
Conclusion:
Cardiac contractility modulation provides safe and effective long-term symptomatic and functional improvement in heart failure. These benefits were independent of baseline LVEF and were associated with a safety profile similar to published device trials.
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