Loading
OPTIMIZER™ Smart Mini System / Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System / Heart Failure · Interventional Study
ClinicalTrials.gov · August 6, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective interventional trial registered to evaluate cardiac contractility modulation (CCM) therapy via the OPTIMIZER Smart Mini System in heart failure patients with ejection fraction ≥40% and ≤70%. The study is currently recruiting and has not yet reported results; primary efficacy endpoints include 6-minute walk distance and Kansas City Cardiomyopathy Questionnaire Clinical Summary Score at 6 months, with safety assessment through 12 months and a hierarchical composite outcome at 18 months.
Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Heart Failure With Moderately Reduced Ejection F…; age from 18 Years. Intervention: CCM Group (CCM ON). Compared with: Sham Group (CCM OFF) — Sham Comparator. n = 1,500. 105 sites: United States.
This is a prospective interventional trial registered to evaluate cardiac contractility modulation (CCM) therapy via the OPTIMIZER Smart Mini System in heart failure patients with ejection fraction ≥40% and ≤70%. The study is currently recruiting and has not yet reported results; primary efficacy endpoints include 6-minute walk distance and Kansas City Cardiomyopathy Questionnaire Clinical Summary Score at 6 months, with safety assessment through 12 months and a hierarchical composite outcome at 18 months.
No safety or efficacy data are available; enrollment status is 'Recruiting' and results are not yet published.
No clinical impact can be assessed from this registry record because no results are reported. Clinicians should monitor for publication of the AIM HIGHer trial results to determine whether CCM therapy has a role in managing patients with heart failure and higher ejection fraction.
This is a clinical trial registry record describing a planned interventional study with no results posted; it represents early-phase evidence gathering in a population (HFpEF/HFmrEF) where CCM therapy is not yet established.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed from this registry record because no results are reported. Clinicians should monitor for publication of the AIM HIGHer trial results to determine whether CCM therapy has a role in managing patients with heart failure and higher ejection fraction.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05064709). This is a study registration, not published results. Lead sponsor: Impulse Dynamics. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 1500 participants (ESTIMATED). Conditions: Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Heart Failure With Moderately Reduced Ejection Fraction, Diastolic Heart Failure. Interventions: DEVICE: Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System; DEVICE: OPTIMIZER™ Smart Mini System. Primary outcome measures: Part 1 Efficacy Endpoint - Change in 6-minute walk distance (6MWD) from baseline to 6 months. , 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). , 6 months; Part 1 Safety Endpoint - The incidence of Optimizer device- or procedure-related complications within the first 12 months after implant , 12 months; Part 2 Endpoint - The hierarchical composite of mortality, morbidity, and health status outcomes (KCCQ CSS). , 18 months. Brief summary: The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.