Assessment of CCM in HF With Higher Ejection Fraction
Impulse Dynamics · NCT05064709
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 1500
- US sites recruiting
- 65
- Study start
- February 3, 2022
- Record last updated
- October 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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%.
Being studied: Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System; OPTIMIZER™ Smart Mini System
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
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Signed and dated informed consent form;
- Male or non-pregnant female, 18 years or older;
- Diagnosed with symptomatic heart failure;
- 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;
- 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.
- 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
- Resting ventricular rate \<50 or >110 bpm;
- Resting systolic blood pressure \<100 or ≥160 mmHg;
- BMI greater than 46
- Any severe valvular stenotic disease or any severe valvular regurgitation;
- Mechanical tricuspid valve;
- Complex congenital heart disease;
- 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;
- Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
- A KCCQ CCS score higher than 85;
- 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;
- Unstable angina pectoris within 30 days prior to study consent;
- 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.
- 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;
- Myocardial infarction within 90 days prior to study consent;
- Prior heart transplant or ventricular assist device;
- Planning to become pregnant during the study;
- Dialysis (permanent) or GFR \<15 ml/min/1.73m2;
- Participating in another investigational drug or device study that may interfere with the interpretation of study data;
- 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;
- Expected lifespan of less than 18 months from time of study consent;
- Unable to follow through study protocol for any reasons (social support, incarceration, mental illness etc.) in the investigator's judgement.
- Insurance denial (after all attempts and appeals have been exhausted, and prior-authorization services utilized, if applicable)
Recruiting US locations
Grandview Medical Group Research, LLC
Birmingham, AL 35243
Site contact: Lauren Bryant · 2059717553 · lauren.bryant@grandviewhealth.com
CardioVascular Associates of Mesa
Mesa, AZ 85206
Site contact: Adam Gitkin · 4806415400 · agitkin@cvam.com
Southwest Cardiovascular Associates
Mesa, AZ 85208
Site contact: Kim Helgeson · 4809454343 · khelgeson@swcva.com
HonorHealth
Scottsdale, AZ 85258
Site contact: Rachel Hultman · rhultman@honorhealth.com
Pima Heart and Vascular
Tuscon, AZ 85712
Site contact: Monica Varela · 5203294139 · monica.varela@pimaheartandvascular.com
University of California San Diego
La Jolla, CA 92093
Site contact: Kendell Oliver · k4oliver@health.ucsd.edu
USC Keck School of Medicine
Los Angeles, CA 90033
Site contact: Melissa Ramos · melissa.ramos@med.usc.edu
Cedars Sinai Medical Center
Los Angeles, CA 90048
Site contact: Goran Stankovic · goran.stankovic@cshs.org
Valley Clinical Trials- Northridge
Northridge, CA 91325
Site contact: Haydee Gutierrez · haydee@valleyclinicaltrials.com
Sequoia Hospital
Redwood City, CA 94062
Site contact: Juanita Fujii · juanita.fujii@commonspirit.org
Nuvance Health - Danbury Hospital
Danbury, CT 06810
Site contact: Tricia Landi · tricia.landi@nuvancehealth.org
Hartford Healthcare
Hartford, CT 06103
Site contact: Jennifer Rossi · jennifer.rossi@hhchealth.org
Nouvelle Clinical Research LLC
Cutler Bay, FL 33189
Site contact: Alexander Cabrera · acabrera@nouvelleclinicalresearch.com
Baptist Health South Florida
Miami, FL 33176
Site contact: Jetsenea Coto · 7865962421 · jetseneac@baptisthealth.net
AdventHealth Orlando
Orlando, FL 32803
Site contact: Chanti Garvey · chantie.garvey@adventhealth.com
Clinical One Research
Orlando, FL 32807
Site contact: Joseniesse Figueroa · jfigueroa@revivalclinical.com
Cleveland Clinic Foundation - Florida Weston Hospital
Weston, FL 33326
Site contact: Maria Mejia Gomez · MEJIAGM@ccf.org
Northeast Georgia Health System
Gainesville, GA 30501
Site contact: Donna Patrick · 678-989-5001 · donna.patrick@nghs.com
Ascension Medical Group St. Vincent
Indianapolis, IN 46260
Site contact: Sabrina Rotondo · sabrina.rotondo@ascension.org
University of Iowa
Iowa City, IA 52242
Site contact: Trisha Elliott · trisha-elliott@uiowa.edu
MercyOne Iowa Heart
West Des Moines, IA 50266
Site contact: Cayla Garner · cayla.barnhart@commonspirit.org
University of Kansas Medical Center
Kansas City, KS 66160
Site contact: Quratulain (Annie) Mushtaq · 9139456488 · qmushtaq@kumc.edu
Baptist Health Lexington
Lexington, KY 40503
Site contact: Kristie Schneider · 8592606429 · kschneid@bhsi.com
Massachusetts General Hospital
Boston, MA 02114
Site contact: Chinemerem Nwokemodo-Ihejirika · cnwokemodo-ihejirika@mgh.harvard.edu
University of Michigan
Ann Arbor, MI 48113
Site contact: Kirsta Bray · kibray@med.umich.edu
Henry Ford St. John Hospital
Detroit, MI 48236
Site contact: Renee Bess · renee.bess@ascension.org
Ascension Providence Hospital
Southfield, MI 48075
Site contact: Candice Edillo · candice.edillo@ascension.org
Trinity health- Michigan Heart
Ypsilanti, MI 48197
Site contact: Autumn Howe · ahowe@michiganheart.com
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, MN 55407
Site contact: Efrah Hussein · 612-863-0666 · jessica.whelan@allina.com
St. Lukes Hospital Kansas City (Mid America Heart Institute)
Kansas City, MO 64111
Site contact: Amanda Huffman · ahuffman@saint-lukes.org
Bryan Heart
Lincoln, NE 68506
Site contact: Nicci Thompson · nicci.thompson@bryanheart.com
Our Lady of Lourdes
Camden, NJ 08103
Site contact: Marisa Brown · 8563551226 · mbrown3@virtua.org
Cooper Hospital- Cardiovascular Associates of Delaware Valley
Haddon Heights, NJ 08035
Site contact: Erin Siderio · 8565822000 · esiderio@hearthousenj.com
Atlantic Health System- Morristown Medical Center
Morristown, NJ 07960
Site contact: Diane Agar · 9739714205 · diane.agar@atlantichealth.org
AtlantiCare Regional Medical Center
Pomona, NJ 08240
Site contact: Jackie White · 609-652-3550 · jmwhite@atlanticare.org
Buffalo General
Buffalo, NY 14203
Site contact: Courtney Bishop · 716-888-4859 · cabishop@buffalo.edu
Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, NY 12601
Site contact: Tricia Landi · 845-473-8675 · tricia.landi@nuvancehealth.org
Cleveland Clinic Foundation
Cleveland, OH 44195
Site contact: Barbara Gus · gusb@ccf.org
Ohio State University Wexner Medical Center
Columbus, OH 43210
Site contact: Maeve McLoughlin · 6142924084 · maeve.mcloughlin@osumc.edu
OhioHealth Research Institute
Columbus, OH 43214
Site contact: Reem (Mimi) Bekheet · reem.bekheet@ohiohealth.com
Oklahoma Heart Institute
Tulsa, OK 74104
Site contact: Colene Holland son · colene.hollandson@oklahomaheart.com
St. Francis Hospital - Tulsa
Tulsa, OK 74136
Site contact: Riley Pritzlaff · 918-502-1606 · rpritzlaff@saintfrancis.com
Providence Heart & Vascular
Portland, OR 97225
Site contact: Sarah Jackson · sarah.jackson3@providence.org
Bryn Mawr Medical Specialists Association
Bryn Mawr, PA 19010
Site contact: Morgan Battiste · mbattiste@bmmsa.com
Penn State Hershey Medical City
Hershey, PA 17033
Site contact: Lisa Fox · lfox5@pennstatehealth.psu.edu
Penn Presbyterian Medical Center
Philadelphia, PA 19104-6061
Site contact: Katie Shoemaker · katie.shoemaker@pennmedicine.upenn.edu
Hospital of the University of Pennsylvania
Philadelphia, PA 19104
Site contact: Emily Marvel · emily.marvel@pennmedicine.upenn.edu
Thomas Jefferson University Hospital
Philadelphia, PA 19107
Site contact: Blaire Cain · 484-756-0929 · blaire.cain@jefferson.edu
Temple University Hospital
Philadelphia, PA 19140
Site contact: Kriti Rawat · kriti.rawat@temple.edu
Allegheny General Hospital
Pittsburgh, PA 15212
Site contact: Kelly Kuniak · Kelly.kuniak4@ahn.org
University of Pittsburgh Medical Center
Pittsburgh, PA 15213
Site contact: Traci McGaha · mcgahatl4@upmc.edu
Prisma Health Upstate
Greenville, SC 29601
Site contact: Kenneth Alfieri · 8644557793 · Kenneth.alfieri@prismahelath.org
North Central Heart
Sioux Falls, SD 57108
Site contact: Robin Farley · rfarley@ncheart.com
The Stern Cardiovascular Foundation
Germantown, TN 38138
Site contact: Kristen Page · kristen.page@sterncardio.com
Ascension Seton
Austin, TX 78723
Site contact: Sarah Benedict · sarah.benedict@ascension.org
Austin Heart
Austin, TX 78756
Site contact: Mary Fraser · Mary.Fraser@hcahealthcare.com
Baylor Scott and White Research Institute
Dallas, TX 75204
Site contact: Tein Luu · 2148651685 · tein.luu@bswhealth.org
Baylor Scott White- All Saints- Fort Worth
Fort Worth, TX 76104
Site contact: Felicity Vaughan · 8179222575 · felicity.vaughan@bswhealth.org
Medical City Fort Worth Hospital
Fort Worth, TX 76104
Site contact: Jessica Blades · Jessica.Blades@HCAhealthcare.com
Baylor College of Medicine
Houston, TX 77030
Site contact: Stephen Harold · harold@bcm.edu
+ 5 more on the official record.
Study contacts (from the official record)
- Gary Cranke · (856) 642-9933 · aimhigher@impulsedynamics.com
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