Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System for Heart Failure with Reduced Ejection Fraction
Phase-Based Progress Estimates
Effectiveness
Safety
Northbay Heart and Vascular, Fairfield, CAHeart Failure with Reduced Ejection Fraction+4 MoreCardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System - Device
Study Summary
This trial will test a new heart failure treatment called Cardiac Contractility Modulation (CCM) therapy. They will test its safety and how well it works in patients with heart failure and a left ventricular ejection fraction (LVEF) between 40 and 60%.
Eligible Conditions
- Heart Failure with Reduced Ejection Fraction
- Heart Failure
- Diastolic Heart Failure
Video Summary
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 0 Secondary · Reporting Duration: 18 months
12 months
Part 1 Safety Endpoint - The incidence of Optimizer device- or procedure-related complications within the first 12 months after implant
18 months
Part 2 Endpoint - The hierarchical composite of mortality, morbidity, and health status outcomes (KCCQ CSS).
6 months
Part 1 Efficacy Endpoint - Change in 6-minute walk distance (6MWD) from baseline to 6 months.
Part 1 Efficacy Endpoint - Change in the health status from baseline to 6 months as assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS).
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Treatment (CCM ON)
1 of 4
CCM Group (CCM ON)
1 of 4
Sham (CCM OFF)
1 of 4
Sham Group (CCM OFF)
1 of 4
Experimental Treatment
Non-Treatment Group
1500 Total Participants · 4 Treatment Groups
Primary Treatment: Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System · Has Placebo Group · N/A
Treatment (CCM ON)
Device
Experimental Group · 1 Intervention: Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System · Intervention Types: DeviceCCM Group (CCM ON)
Device
Experimental Group · 1 Intervention: Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System · Intervention Types: DeviceSham (CCM OFF)
Device
ShamComparator Group · 1 Intervention: Sham Therapy · Intervention Types: DeviceSham Group (CCM OFF)
Device
ShamComparator Group · 1 Intervention: OPTIMIZER™ Smart Mini System · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months
Who is running the clinical trial?
Impulse DynamicsLead Sponsor
10 Previous Clinical Trials
1,928 Total Patients Enrolled
Javed Butler, MD, MPH, MBAPrincipal InvestigatorDepartment of Medicine, University of Mississippi Medical Center, Jackson, MS, USA
1 Previous Clinical Trials
27 Total Patients Enrolled
Oussama Wazni, MD, MBAPrincipal InvestigatorDepartment of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have heart failure and are experiencing symptoms.
Who else is applying?
What state do they live in?
| New York | 40.0% |
| Indiana | 20.0% |
| Arizona | 20.0% |
| Other | 20.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Baptist Health Lexington | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Abraham, William T., Karl-Heinz Kuck, Rochelle L. Goldsmith, JoAnn Lindenfeld, Vivek Y. Reddy, Peter E. Carson, Douglas L. Mann, et al.. 2018. “A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation”. JACC: Heart Failure. Elsevier BV. doi:10.1016/j.jchf.2018.04.010.
- Wiegn, Phi, Rodrigo Chan, Charles Jost, Benjamin R. Saville, Helen Parise, David Prutchi, Peter E. Carson, Angela Stagg, Rochelle L. Goldsmith, and Daniel Burkhoff. 2020. “Safety, Performance, and Efficacy of Cardiac Contractility Modulation Delivered by the 2-lead Optimizer Smart System”. Circulation: Heart Failure. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circheartfailure.119.006512.
- Tschöpe, Carsten, Sophie Van Linthout, Frank Spillmann, Oliver Klein, Sebastian Biewener, Andrew Remppis, David Gutterman, et al.. 2016. “Cardiac Contractility Modulation Signals Improve Exercise Intolerance and Maladaptive Regulation of Cardiac Key Proteins for Systolic and Diastolic Function in Hfpef”. International Journal of Cardiology. Elsevier BV. doi:10.1016/j.ijcard.2015.10.208.
- Tschöpe, Carsten, Javed Butler, Dimitrios Farmakis, Deborah Morley, Ishu Rao, and Gerasimos Filippatos. 2020. “Clinical Effects of Cardiac Contractility Modulation in Heart Failure with Mildly Reduced Systolic Function”. ESC Heart Failure. Wiley. doi:10.1002/ehf2.13126.
- Tschöpe C, Butler J, Farmakis D, Morley D, Rao I, Filippatos G. Clinical effects of cardiac contractility modulation in heart failure with mildly reduced systolic function. ESC Heart Fail. 2020 Dec;7(6):3531-3535. doi: 10.1002/ehf2.13126. Epub 2020 Dec 3.
- Tschope C, Van Linthout S, Spillmann F, Klein O, Biewener S, Remppis A, Gutterman D, Linke WA, Pieske B, Hamdani N, Roser M. Cardiac contractility modulation signals improve exercise intolerance and maladaptive regulation of cardiac key proteins for systolic and diastolic function in HFpEF. Int J Cardiol. 2016 Jan 15;203:1061-6. doi: 10.1016/j.ijcard.2015.10.208. Epub 2015 Oct 27. No abstract available.
- Abraham WT, Kuck KH, Goldsmith RL, Lindenfeld J, Reddy VY, Carson PE, Mann DL, Saville B, Parise H, Chan R, Wiegn P, Hastings JL, Kaplan AJ, Edelmann F, Luthje L, Kahwash R, Tomassoni GF, Gutterman DD, Stagg A, Burkhoff D, Hasenfuss G. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation. JACC Heart Fail. 2018 Oct;6(10):874-883. doi: 10.1016/j.jchf.2018.04.010. Epub 2018 May 10.
- Tschope C, Butler J, Farmakis D, Morley D, Rao I, Filippatos G. Clinical effects of cardiac contractility modulation in heart failure with mildly reduced systolic function. ESC Heart Fail. 2020 Dec;7(6):3531-3535. doi: 10.1002/ehf2.13126. Epub 2020 Dec 3.
- Abraham WT, Kuck KH, Goldsmith RL, Lindenfeld J, Reddy VY, Carson PE, Mann DL, Saville B, Parise H, Chan R, Wiegn P, Hastings JL, Kaplan AJ, Edelmann F, Luthje L, Kahwash R, Tomassoni GF, Gutterman DD, Stagg A, Burkhoff D, Hasenfuss G. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation. JACC Heart Fail. 2018 Oct;6(10):874-883. doi: 10.1016/j.jchf.2018.04.010. Epub 2018 May 10. Erratum In: JACC Heart Fail. 2023 Jan;11(1):132.
- 2022. "Assessment of CCM in HF With Higher Ejection Fraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05064709.
Frequently Asked Questions
Are participants still welcome to enroll in this research?
"This clinical investigation is currently seeking enrollees; the trial was initially posted on February 3rd 2022 and underwent its most recent update on November 29th of that same year." - Anonymous Online Contributor
Unverified Answer
How many sites is this clinical trial being administered at?
"The USC Keck School of Medicine in Los Angeles, Florida Broward Health in Fort Lauderdale, Ohio and AdventHealth Orlando in Orlando Texas are all recruiting participants for the trial. Additionally, there are 53 additional sites that have been selected to receive patients." - Anonymous Online Contributor
Unverified Answer
How many participants are taking part in this clinical experiment?
"Impulse Dynamics, the study sponsor, will coordinate a total of 1500 participants meeting all inclusion criteria across various sites such as USC Keck School of Medicine in Los Angeles, Florida and Broward Health in Fort Lauderdale." - Anonymous Online Contributor
Unverified Answer