Actively Recruiting
Assessment of Implantable Cardiac Contractility Modulation Therapy in Heart Failure Patients With Higher Ejection Fraction
Led by Impulse Dynamics · Updated on 2026-05-06
1500
Participants Needed
105
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of Cardiac Contractility Modulation CCM therapy in people with heart failure who have a left ventricular ejection fraction LVEF between 40 and 70. This clinical trial includes two parts with separate scientific goals Part I focuses on functional capacity and health status, while Part II evaluates clinical outcomes. The study is randomized, quadruple-blind, and sham-controlled, involving subjects from about 225 sites worldwide. Participants will have an OPTIMIZER Smart Mini System implanted that delivers CCM therapy. They will be randomly assigned in a 21 ratio to either have CCM therapy turned ON continuously or to a sham group with CCM therapy turned OFF for the first 18 months. After 18 months, the sham group will also have CCM therapy turned ON. CCM therapy consists of seven one-hour sessions distributed evenly over each 24-hour period. The study includes follow-up through both parts, lasting up to several years. During the study, participants will undergo screening and baseline testing before implantation. Researchers will measure changes in walking distance over six minutes and health status by the Kansas City Cardiomyopathy Questionnaire after six months. Safety will be assessed by tracking device- or procedure-related complications for 12 months. Clinical outcomes including mortality, morbidity, and health status will be reviewed after 18 months. Participants will be monitored regularly for these outcomes throughout the study duration.
CONDITIONS
Brief Title
Assessment of CCM in HF With Higher Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Male or non-pregnant female, 18 years or older
- Diagnosed with symptomatic heart failure
- Left ventricular ejection fraction between 40% and 70% as assessed by echocardiogram
- Heart failure hospitalization within 12 months prior to consent OR urgent heart failure visit requiring IV therapy within 6 months prior to consent OR elevated BMI-adjusted natriuretic peptide if no recent hospitalization or urgent visit
- Stable, scheduled oral loop diuretic treatment for at least 30 days before consent or eligibility maintained on SGLT2 inhibitor with flexible PRN diuretic regimen
You will not qualify if you...
- Resting ventricular rate less than 50 or greater than 110 beats per minute
- Resting systolic blood pressure less than 100 or equal to or greater than 160 mmHg
- Body mass index greater than 46
- Severe valvular stenotic disease or severe valvular regurgitation
- Mechanical tricuspid valve
- Complex congenital heart disease
- Exercise intolerance caused by conditions other than heart failure
- Unable to walk at least 100 meters or can walk more than 450 meters during a 6-minute walk test
- Kansas City Cardiomyopathy Questionnaire Clinical Summary Score higher than 85
- Hypertrophic, infiltrative/restrictive, or inflammatory cardiomyopathy
- Unstable angina within 30 days prior to consent
- Acute decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent
- Receiving cardiac resynchronization therapy unless implanted more than one year ago and classified as NYHA class III or higher
- Scheduled or recent cardiac surgery or percutaneous cardiac intervention
- Myocardial infarction within 90 days prior to consent
- Prior heart transplant or ventricular assist device
- Planning pregnancy during the study
- Permanent dialysis or severe kidney dysfunction
- Participation in another investigational drug or device study that may interfere
- Active chemotherapy or radiation treatment for cancer or treatment within two years prior to consent
- Expected lifespan less than 18 months
- Unable to follow study protocol as judged by investigator
Research Team
R
Rachael Riccitello
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