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Assessment of CCM in HF With Higher Ejection Fraction

Recruiting

Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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). A historical echo within 60 days of consent may be used for baseline. Ultrafiltration should not be performed within 30 days of echo;
5. Subjects must meet at least one of the four following criteria:

   I. Heart failure admission (primary or secondary) within 12 months prior to study consent OR heart failure visit requiring IV therapy OR treated with outpatient Furoscix OR intensification of oral diuresis within 6 months prior to study consent II. PCWP \> 15 mmHg up to 6 months prior to consent or within 30 days following consent III. IPAP reading of mean pressure ≥ 22 mmHg in 2 or more readings within 30 days of consent, or 3 or more readings within 60 days across different days, with a sensor implanted ≥ 3 months before first reading

   IV. Natriuretic peptide value (NTproBNP or BNP) should meet or exceed the value below, depending on the presenting rhythm:
   * Normal Sinus Rhythm (NSR): NTproBNP (pg/ml) ≥ 150 or BNP (pg/ml) ≥ 50
   * Atrial Tachyarrhythmia (AT): NTproBNP (pg/ml) ≥ 450 or BNP (pg/ml) ≥ 150
   * Historical natriuretic peptide values within 6 months of consent may be used if subject is in NSR. Subjects in AT on baseline ECG must have natriuretic peptide values collected post-consent.
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. Spironolactone used as a diuretic for patients who cannot tolerate oral loop diuretic is an acceptable alternative.
   * 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. Diagnosis of any of the following conditions that, in the opinion of the investigator, contributes significantly to the primary symptoms of exercise intolerance: angina, significant pulmonary disease, or currently requires 24-hour home oxygen use or scheduled oral steroids, peripheral vascular disease, orthopedic or rheumatologic conditions;
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. Infiltrative/restrictive (e.g., amyloidosis, sarcoidosis, hemochromatosis, Fabry, or radiation-induced heart disease), eccentric LV hypertrophy or inflammatory cardiomyopathy as documented in the medical record;
11. Unstable angina pectoris within 30 days prior to study consent;
12. 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.
13. 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;
14. Myocardial infarction within 90 days prior to study consent;
15. Prior heart transplant or ventricular assist device;
16. Planning to become pregnant during the study;
17. Dialysis (permanent) or GFR \<15 ml/min/1.73m2;
18. Participating in another investigational drug or device study that may interfere with the interpretation of study data;
19. 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;
20. Expected lifespan of less than 18 months from time of study consent;
21. Unable to follow through study protocol for any reasons (social support, incarceration, mental illness etc.) in the investigator's judgement.
22. Insurance denial (after all attempts and appeals have been exhausted, and prior-authorization services utilized, if applicable)

About the study

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%.

What is being tested

Sponsor: Impulse Dynamics · Participants: 1,500 · Started: Feb 3, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05064709

Locations in the U.S.

AlabamaGrandview Medical Group Research, LLC, Birmingham
ArizonaCardioVascular Associates of Mesa, Mesa
Southwest Cardiovascular Associates, Mesa
HonorHealth, Scottsdale
Pima Heart and Vascular, Tuscon
CaliforniaUniversity of California San Diego, La Jolla
Cedars Sinai Medical Center, Los Angeles
USC Keck School of Medicine, Los Angeles
Valley Clinical Trials- Northridge, Northridge
Sequoia Hospital, Redwood City
ConnecticutNuvance Health - Danbury Hospital, Danbury
Hartford Healthcare, Hartford
FloridaNouvelle Clinical Research LLC, Cutler Bay
Baptist Health South Florida, Miami
AdventHealth Orlando, Orlando
Clinical One Research, Orlando
Cleveland Clinic Foundation - Florida Weston Hospital, Weston
GeorgiaNortheast Georgia Health System, Gainesville
IndianaAscension Medical Group St. Vincent, Indianapolis
IowaUniversity of Iowa, Iowa City
MercyOne Iowa Heart, West Des Moines
KansasUniversity of Kansas Medical Center, Kansas City
KentuckyBaptist Health Lexington, Lexington
MassachusettsMassachusetts General Hospital, Boston
MichiganUniversity of Michigan, Ann Arbor
Henry Ford St. John Hospital, Detroit
Ascension Providence Hospital, Southfield
Trinity health- Michigan Heart, Ypsilanti
MinnesotaMinneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis
MissouriSt. Lukes Hospital Kansas City (Mid America Heart Institute), Kansas City
NebraskaBryan Heart, Lincoln
New JerseyOur Lady of Lourdes, Camden
Cooper Hospital- Cardiovascular Associates of Delaware Valley, Haddon Heights
Atlantic Health System- Morristown Medical Center, Morristown
AtlantiCare Regional Medical Center, Pomona
New YorkBuffalo General, Buffalo
Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC, Poughkeepsie
OhioCleveland Clinic Foundation, Cleveland
Ohio State University Wexner Medical Center, Columbus
OhioHealth Research Institute, Columbus
OklahomaOklahoma Heart Institute, Tulsa
St. Francis Hospital - Tulsa, Tulsa
OregonProvidence Heart & Vascular, Portland
PennsylvaniaBryn Mawr Medical Specialists Association, Bryn Mawr
Penn State Hershey Medical City, Hershey
Hospital of the University of Pennsylvania, Philadelphia
Penn Presbyterian Medical Center, Philadelphia
Temple University Hospital, Philadelphia
Thomas Jefferson University Hospital, Philadelphia
Allegheny General Hospital, Pittsburgh
University of Pittsburgh Medical Center, Pittsburgh
South CarolinaPrisma Health Upstate, Greenville
South DakotaNorth Central Heart, Sioux Falls
TennesseeThe Stern Cardiovascular Foundation, Germantown
TexasAscension Seton, Austin
Austin Heart, Austin
Baylor Scott and White Research Institute, Dallas
Baylor Scott White- All Saints- Fort Worth, Fort Worth
Medical City Fort Worth Hospital, Fort Worth
Baylor College of Medicine, Houston
Houston Methodist, Houston
Memorial Hermann Texas Medical Center, Houston
VirginiaBon Secours St. Mary's, Richmond
WashingtonSwedish Medical Center, Seattle
Peace Health, Vancouver

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.