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Updated: Sep 4, 2025

Evaluation of Cardiac Contractility Modulation Therapy in 2D Human Stem Cell-Derived Cardiomyocytes
Published on: December 16, 2022
Cardiac contractility modulation therapy improves health status in patients with heart failure with preserved
Cecilia Linde1, Marcin Grabowski2, Piotr Ponikowski3
1Heart, Vascular and Neurology Theme, Karolinska University Hospital and the Karolinska Institutet, Stockholm, Sweden.
Insights
Cardiac Contractility Modulation (CCM) shows promise for heart failure with preserved ejection fraction (HFpEF) patients. This pilot study found significant health status improvements with CCM therapy, indicating a potential new treatment option for HFpEF.
Area of Science:
- Cardiology
- Medical Devices
- Heart Failure Research
Background:
- Heart failure with preserved ejection fraction (HFpEF) affects a significant patient population.
- Current treatment options for HFpEF are limited, highlighting the need for novel therapeutic approaches.
- Cardiac Contractility Modulation (CCM) is an emerging technology for heart failure management.
Purpose of the Study:
- To evaluate the safety and efficacy of CCM therapy in patients diagnosed with HFpEF.
- To assess the impact of CCM on the health status of HFpEF patients.
- To determine the feasibility of CCM as a treatment for HFpEF.
Main Methods:
- A prospective, multicentre, single-arm pilot study involving 47 patients with HFpEF (NYHA class II-III).
- CCM device implantation followed by a 24-week follow-up period.
- Echocardiographic parameters assessed for eligibility; Kansas City Cardiomyopathy Questionnaire (KCCQ) used for health status evaluation.
Main Results:
- Significant improvement in KCCQ overall summary score by 18.0 points (p < 0.001).
- High event-free rate of 93.6% for the primary safety endpoint (device/procedure complications).
- The study population comprised older adults, predominantly female, with common comorbidities like hypertension and atrial fibrillation.
Conclusions:
- CCM therapy demonstrates potential benefits in the HFpEF patient population.
- Significant improvements in health status were observed without compromising safety.
- CCM may represent a promising therapeutic strategy for managing HFpEF.
Aims:
This pilot study aimed to assess the potential benefits of cardiac contractility modulation (CCM) in patients with heart failure with preserved ejection fraction (HFpEF).
Methods And Results:
This was a prospective, multicentre, single-arm, pilot study of CCM therapy in patients with HFpEF and New York Heart Association (NYHA) class II or III. Echocardiographic parameters were measured by an echo core laboratory to determine study eligibility. After CCM device implantation, patients were followed for 24 weeks. Overall, 47 patients (mean age 74.3 ± 4.4 years, 70.2% female) were enrolled, with left ventricular ejection fraction of 59 ± 4.4%, 63.8% with hypertension, 46.8% with atrial fibrillation, 40.4% with diabetes, 31.9% with at least one heart failure hospitalization in the prior year, 61.7% in NYHA class III, and Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of 48.9 ± 21.7. The primary efficacy endpoint (mean change in the KCCQ overall summary score) improved by 18.0 ± 16.6 points (p < 0.001) and there was an event-free rate of 93.6% for the primary safety endpoint (device- and procedure-related complications), as adjudicated by an independent physician committee.
Conclusion:
This pilot study demonstrates that the benefits of CCM may extend to the HFpEF patient population. The significant improvement in health status observed, with no obvious impact on safety, suggests that utilization of CCM for patients with HFpEF could prove to be promising.
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