Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System for Heart Failure with Reduced Ejection Fraction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Northbay Heart and Vascular, Fairfield, CAHeart Failure with Reduced Ejection Fraction+4 MoreCardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

1 of 3

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: Device
CCM Group (CCM ON)
Device
Experimental Group · 1 Intervention: Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System · Intervention Types: Device
Sham (CCM OFF)
Device
ShamComparator Group · 1 Intervention: Sham Therapy · Intervention Types: Device
Sham Group (CCM OFF)
Device
ShamComparator Group · 1 Intervention: OPTIMIZER™ Smart Mini System · Intervention Types: Device

Trial 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 York40.0%
Indiana20.0%
Arizona20.0%
Other20.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Baptist Health Lexington100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

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
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.