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Clinical Trials in the USA / NCT05064709
Recruiting Not applicable

Assessment of CCM in HF With Higher Ejection Fraction

NCT05064709 · tracked via the Priya Life Science USA tracker
Sponsor
Impulse Dynamics
Phase
Not applicable
Started
2022-02-03
Last updated
2026-08-06

Condition(s) studied

Heart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection FractionHeart Failure With Moderately Reduced Ejection FractionDiastolic Heart Failure

Investigational drug(s) / intervention(s)

Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini SystemOPTIMIZER™ Smart Mini System

Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System: The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed ON for the first 18 months (blinded phase). CCM therapy will be programmed to deliver 7 one-hour phases of CCM therapy that are distributed equally over every 24-hour period. CCM will remain on following completion of the 18-month visit.

OPTIMIZER™ Smart Mini System: The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed OFF for the first 18 months (blinded phase). CCM will be turned on following completion of the 18-month visit.

Study 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%.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Signed and dated informed consent form; 2. Male or non-pregnant female, 18 years or older; 3. Diagnosed with symptomatic heart failure; 4. LVEF ≥40 and ≤70% (as assessed by site echo); 5. A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent OR B. If there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, an elevated BMI-adjusted natriuretic peptide value must be achieved (Refer to Table 1 in Section 9.2.6) 6. Subjects must meet one of the following conditions: * Have stable, scheduled oral loop diuretic treatment (not just PRN) for a minimum of 30 days before providing study consent unless there is a documented allergy or intolerance. * Eligibility for enrollment is maintained for patients on an SGLT2 inhibitor without prescribed concurrent standing loop diuretic therapy if investigators provide instructions for a flexible PRN diuretic regimen (deemed appropriate by the clinician in response to symptoms or weight gain) Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days. A one-time hold of diuretic dosing for 24 hours during the 30-day period is allowed and not an exclusionary event. Exclusion Criteria: 1. Resting ventricular rate \<50 or \>110 bpm; 2. Resting systolic blood pressure \<100 or ≥160 mmHg; 3. BMI greater than 46 4. Any severe valvular stenotic disease or any severe valvular regurgitation; 5. Mechanical tricuspid valve; 6. Complex congenital heart disease; 7. Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and/or exercise intolerance; 8. Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT; 9. A KCCQ CCS score higher than 85; 10. Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy; 11. Unstable angina pectoris within 30 days prior to study consent; 12. Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting; 13. Receiving cardiac resynchronization therapy (CRT); NOTE: Subjects with active/ongoing cardiac resynchronization therapy (CRT) implanted more than one year ago are eligible for inclusion if they are currently classified as NYHA class III or higher. 14. Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent; 15. Myocardial infarction within 90 days prior to study consent; 16. Prior heart transplant or ventricular assist device; 17. Planning to become pregnant during the study; 18. Dialysis (permanent) or GFR \<15 ml/min/1.73m2; 19. Participating in another investigational drug or device study that may interfere with the interpretation of study data; 20. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent; 21. Expected lifespan of less than 18 months from time of study consent; 22. Unable to follow through study protocol for any reasons in the investigator's judgement.

Primary outcome measure(s)

Trial sites (105)

FacilityCityRegionStatus
Grandview Medical Group Research, LLC Birmingham Alabama Recruiting
CardioVascular Associates of Mesa Mesa Arizona Recruiting
Chan Heart Rhythm Institute Mesa Arizona Recruiting
Southwest Cardiovascular Associates Mesa Arizona Recruiting
Arizona Heart Rhythm Phoenix Arizona Recruiting
Cardiovascular Consultants, Ltd Phoenix Arizona Recruiting
HonorHealth Scottsdale Arizona Recruiting
Pima Heart and Vascular Tuscon Arizona Recruiting
John Muir Health Concord California Recruiting
University of California San Diego La Jolla California Recruiting
USC Keck School of Medicine Los Angeles California Recruiting
Cedars Sinai Medical Center Los Angeles California Recruiting
Valley Clinical Trials- Northridge Northridge California Recruiting
Sequoia Hospital Redwood City California Recruiting
University of California Davis Health Sacramento California Withdrawn
University of California, San Francisco San Francisco California Withdrawn
Nuvance Health - Danbury Hospital Danbury Connecticut Recruiting
Hartford Healthcare Hartford Connecticut Recruiting
HCA Florida JFK Hospital Atlantis Florida Recruiting
Nouvelle Clinical Research LLC Cutler Bay Florida Recruiting
Broward Health Fort Lauderdale Florida Recruiting
Memorial Healthcare System Hollywood Florida Withdrawn
Baptist Health South Florida Miami Florida Recruiting
NCA Research Institute - Florida Naples Florida Withdrawn
AdventHealth Orlando Orlando Florida Recruiting
Revival Clinical Research Orlando Florida Recruiting
Tallahassee Research Institute Tallahassee Florida Withdrawn
Cleveland Clinic Foundation - Florida Weston Hospital Weston Florida Recruiting
Piedmont Healthcare Atlanta Georgia Withdrawn
Franciscan Health Indianapolis Indianapolis Indiana Withdrawn
Ascension Medical Group St. Vincent Indianapolis Indiana Recruiting
University of Iowa Iowa City Iowa Recruiting
MercyOne Iowa Heart West Des Moines Iowa Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Kansas City Cardiac Arrhythmia Research LLC Overland Park Kansas Recruiting
Baptist Health Lexington Lexington Kentucky Recruiting
Ochsner Clinic Foundation New Orleans Louisiana Withdrawn
Massachusetts General Hospital Boston Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Henry Ford St. John Hospital Detroit Michigan Recruiting

+ 65 more sites — see the full list on the official registry below.

More Impulse Dynamics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05064709 on ClinicalTrials.gov ↗ ← All trials in the USA