Cardiac Contractility Modulation Therapy in Heart Failure
This study is looking at how Cardiac Contractility Modulation (CCM) therapy affects people with heart failure. CCM uses a device called the Optimizer System, which is implanted to deliver electrical signals to your heart. These signals help your heart muscle contract more strongly. The study aims to see if CCM can reduce hospitalizations for heart failure or death in patients with heart failure and reduced ejection fraction (meaning your heart doesn't pump blood as well as it should) who are in NYHA Class III (meaning you have noticeable limits on your physical activity). You might be able to join if you are 18 or older, have NYHA Class III heart failure, and your heart's ejection fraction is between 25% and 45%. The study will track how long it takes for a patient to have their first heart failure hospitalization or death from any cause, for up to two years. The current status of this study is unclear.
- Study design
- This is an observational study comparing patients who receive CCM therapy to a similar group of patients who do not. It plans to include about 4200 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to two years after receiving CCM therapy or being identified in the control group.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
At a glance
Conditions
NCT07209098
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Impulse Dynamics
Marlton, New Jerseystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Time to first heart failure hospitalization or all-cause deathUp to 2 years post-index date for each patient; follow-up will continue until 2 years after the last patient is enrolled to allow at least 2 years of observation for all participants.
Time from index date to the first occurrence of either heart failure-related hospitalization or death in patients with a clinical indication for cardiac contractility modulation (CCM) therapy. Outcomes will be compared between patients implanted with the Optimizer System (treatment arm) and a propensity score-matched control group of patients who are eligible for CCM but did not receive the device. Data will be collected from a large, de-identified, multi-system electronic health record database representing diverse sites of care across the United States.