Assessment of CCM in HF With Higher Ejection Fraction
Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe and effective Cardiac Contractility Modulation (CCM) therapy is for heart failure. It is for adults with heart failure symptoms whose left heart chamber pumps out 40% to 70% of its blood with each beat.
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%.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Sign and date a form agreeing to join the study.
- Be age 18 or older and not pregnant.
- Have heart failure that causes symptoms.
- Have a left ventricular ejection fraction (LVEF) of 40% to 70%, measured by a heart ultrasound. This is the share of blood pumped out with each beat.
- Have had a heart failure hospital stay in the past 12 months or an urgent heart failure visit needing medicine through a vein in the past 6 months. Otherwise, a blood marker of heart strain must meet a required level adjusted for body size.
- Take a scheduled loop diuretic (water pill) by mouth for at least 30 days before joining, unless you have a documented allergy or cannot tolerate it. The dose must not have more than doubled or dropped by more than half during that time; one 24-hour pause is allowed.
- Instead of scheduled water pills, you may take an SGLT2 inhibitor medicine if the study doctor gives you a plan to take water pills as needed for symptoms or weight gain.
Who can't join
- Resting heart rate below 50 or above 110 beats per minute; top blood pressure number below 100 or at least 160; or body mass index (BMI, a measure of weight for height) above 46.
- Severely narrowed or leaky heart valves; a mechanical tricuspid valve; a complex heart problem present at birth; or certain heart muscle diseases involving thickening, buildup, stiffness, or inflammation.
- Another condition greatly limits exercise or causes shortness of breath; you walk less than 100 or more than 450 meters in 6 minutes; or your KCCQ CCS heart failure health survey score is above 85.
- New or worsening heart-related chest pain in the past 30 days; worsening heart failure needing treatment through a vein or blood filtering to remove fluid in the past 30 days; or a heart attack in the past 90 days.
- Heart surgery or a catheter-based heart procedure is planned; heart surgery occurred in the past 90 days or a catheter-based procedure in the past 30 days; or you have had a heart transplant or heart pump device.
- You receive cardiac resynchronization therapy (CRT), which helps the heart's chambers beat together. An exception applies if it was implanted more than a year ago and you still have heart failure classed as NYHA III or higher, meaning marked limits on activity or worse.
- You plan to become pregnant; need permanent dialysis or have a kidney filtering rate below 15; are receiving chemotherapy or radiation for cancer; or had chemotherapy in the past 2 years.
- You are in another drug or device study that could affect these results; are expected to live less than 18 months; or the study doctor believes you cannot follow the study plan.
Simplified for readability. The official criteria below are what the study team uses.
Official 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); 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.
Study sites (105)
AL
- Grandview Medical Group Research, LLC · Birmingham, AL 35243Lauren Bryant · Study contact · 2059717553 · lauren.bryant@grandviewhealth.comMore trials in Birmingham
AZ
- CardioVascular Associates of Mesa · Mesa, AZ 85206Adam Gitkin · Study contact · 4806415400 ext. 2107 · agitkin@cvam.comMore trials in Mesa
- Chan Heart Rhythm Institute · Mesa, AZ 85206Olivia Rivera · Study contact · olivia@chanheartrhythm.comMore trials in Mesa
- Southwest Cardiovascular Associates · Mesa, AZ 85208Kim Helgeson · Study contact · 4809454343 ext. 244 · khelgeson@swcva.comMore trials in Mesa
- Arizona Heart Rhythm · Phoenix, AZ 85016Brandon Buscaglia · Study contact · bbuscaglia@azheartrhythm.comMore trials in Phoenix
- Cardiovascular Consultants, Ltd · Phoenix, AZ 85032Helen Foughi · Study contact · hfoughi@insightmedr.comMore trials in Phoenix
- HonorHealth · Scottsdale, AZ 85258Rachel Hultman · Study contact · rhultman@honorhealth.comMore trials in Scottsdale
- Pima Heart and Vascular · Tuscon, AZ 85712Monica Varela · Study contact · 5203294139 · monica.varela@pimaheartandvascular.comMore trials in Tuscon
CA
- John Muir Health · Concord, CA 94520Rita Trachuk · Study contact · rita.trachuk@johnmuirhealth.comMore trials in Concord
- University of California San Diego · La Jolla, CA 92093Kendell Oliver · Study contact · k4oliver@health.ucsd.eduMore trials in La Jolla
- USC Keck School of Medicine · Los Angeles, CA 90033Melissa Ramos · Study contact · melissa.ramos@med.usc.eduSilvia Perez · Study contact · silvia.perez@med.usc.eduMore trials in Los Angeles
- Cedars Sinai Medical Center · Los Angeles, CA 90048Goran Stankovic · Study contact · goran.stankovic@cshs.orgMore trials in Los Angeles
- Valley Clinical Trials- Northridge · Northridge, CA 91325Haydee Gutierrez · Study contact · haydee@valleyclinicaltrials.comMore trials in Northridge
- Sequoia Hospital · Redwood City, CA 94062Juanita Fujii · Study contact · juanita.fujii@commonspirit.orgMore trials in Redwood City
- University of California Davis Health · Sacramento, CA 95817More trials in Sacramento
- University of California, San Francisco · San Francisco, CA 94143More trials in San Francisco
CT
- Nuvance Health - Danbury Hospital · Danbury, CT 06810Tricia Landi · Study contact · tricia.landi@nuvancehealth.orgMore trials in Danbury
- Hartford Healthcare · Hartford, CT 06103Jennifer Rossi · Study contact · jennifer.rossi@hhchealth.orgMore trials in Hartford
FL
- HCA Florida JFK Hospital · Atlantis, FL 33462Elizabeth Diebel · Study contact · Elizabeth.Diebel@hcahealthcare.comMore trials in Atlantis
- Nouvelle Clinical Research LLC · Cutler Bay, FL 33189Alexander Cabrera · Study contact · acabrera@nouvelleclinicalresearch.comNilda Cespedes · Study contact · ncespedes@nouvelleclinicalresearch.comMore trials in Cutler Bay
- Broward Health · Fort Lauderdale, FL 33316Laura Hudson · Study contact · lhudson@browardhealth.orgMore trials in Fort Lauderdale
- Memorial Healthcare System · Hollywood, FL 33021More trials in Hollywood
- Baptist Health South Florida · Miami, FL 33176Jetsenea Coto · Study contact · 7865962421 · jetseneac@baptisthealth.netMore trials in Miami
- NCA Research Institute - Florida · Naples, FL 34102More trials in Naples
- AdventHealth Orlando · Orlando, FL 32803Chanti Garvey · Study contact · chantie.garvey@adventhealth.comMore trials in Orlando
- Revival Clinical Research · Orlando, FL 32807Joseniesse Figueroa · Study contact · jfigueroa@revivalclinical.comMore trials in Orlando
- Tallahassee Research Institute · Tallahassee, FL 32308More trials in Tallahassee
- Cleveland Clinic Foundation - Florida Weston Hospital · Weston, FL 33326Maria Mejia Gomez · Study contact · MEJIAGM@ccf.orgMore trials in Weston
GA
- Piedmont Healthcare · Atlanta, GA 30309More trials in Atlanta
IA
- University of Iowa · Iowa City, IA 52242Trisha Elliott · Study contact · trisha-elliott@uiowa.eduMore trials in Iowa City
- MercyOne Iowa Heart · West Des Moines, IA 50266Cayla Garner · Study contact · cayla.barnhart@commonspirit.orgMore trials in West Des Moines
IN
- Franciscan Health Indianapolis · Indianapolis, IN 46237More trials in Indianapolis
- Ascension Medical Group St. Vincent · Indianapolis, IN 46260Sabrina Rotondo · Study contact · sabrina.rotondo@ascension.orgMore trials in Indianapolis
KS
- University of Kansas Medical Center · Kansas City, KS 66160Quratulain (Annie) Mushtaq · Study contact · 9139456488 · qmushtaq@kumc.eduMore trials in Kansas City
- Kansas City Cardiac Arrhythmia Research LLC · Overland Park, KS 66211Donita Atkins · Study contact · donita.atkins@hcahealthcare.comJenny Bush · Study contact · jennifer.bush2@hcahealthcare.comMore trials in Overland Park
KY
- Baptist Health Lexington · Lexington, KY 40503Kristie Schneider · Study contact · 8592606429 · kschneid@bhsi.comMore trials in Lexington
LA
- Ochsner Clinic Foundation · New Orleans, LA 70121More trials in New Orleans
MA
- Massachusetts General Hospital · Boston, MA 02114Chinemerem Nwokemodo-Ihejirika · Study contact · cnwokemodo-ihejirika@mgh.harvard.eduMore trials in Boston
MI
- University of Michigan · Ann Arbor, MI 48113Kirsta Bray · Study contact · kibray@med.umich.eduThomas Crawford, MD · Principal investigatorMore trials in Ann Arbor
- Henry Ford St. John Hospital · Detroit, MI 48236Renee Bess · Study contact · renee.bess@ascension.orgMore trials in Detroit
- Ascension Providence Hospital · Southfield, MI 48075Candice Edillo · Study contact · candice.edillo@ascension.orgMore trials in Southfield
- Trinity health- Michigan Heart · Ypsilanti, MI 48197Autumn Howe · Study contact · ahowe@michiganheart.comMore trials in Ypsilanti
MN
- Minneapolis Heart Institute at Abbott Northwestern Hospital · Minneapolis, MN 55407Efrah Hussein · Study contact · 612-863-0666 · jessica.whelan@allina.comMore trials in Minneapolis
MO
- St. Louis Heart and Vascular · Bridgeton, MO 63044Paige Brown · Study contact · 3147410911 ext. 4044 · pbrown@slhv.comMore trials in Bridgeton
- St. Luke's Hospital · Chesterfield, MO 63017More trials in Chesterfield
- St. Lukes Hospital Kansas City (Mid America Heart Institute) · Kansas City, MO 64111Amanda Huffman · Study contact · ahuffman@saint-lukes.orgMore trials in Kansas City
MS
- North Mississippi Medical Center · Tupelo, MS 38801More trials in Tupelo
NC
- Sanger Heart and Vascular · Charlotte, NC 28203More trials in Charlotte
NE
- Bryan Heart · Lincoln, NE 68506Nicci Thompson · Study contact · nicci.thompson@bryanheart.comMore trials in Lincoln
- University of Nebraska Medical Center · Omaha, NE 68198-5331More trials in Omaha
NH
- Catholic Medical Center · Manchester, NH 03102More trials in Manchester
NJ
- Our Lady of Lourdes · Camden, NJ 08103Marisa Brown · Study contact · 8563551226 · mbrown3@virtua.orgMore trials in Camden
- Hackensack University Medical Center · Edison, NJ 08837More trials in Edison
- Jersey Shore University Medical Center · Edison, NJ 08837More trials in Edison
- Cooper Hospital- Cardiovascular Associates of Delaware Valley · Haddon Heights, NJ 08035Erin Siderio · Study contact · 8565822000 ext. 5207 · esiderio@hearthousenj.comMore trials in Haddon Heights
- Atlantic Health System- Morristown Medical Center · Morristown, NJ 07960Diane Agar · Study contact · 9739714205 · diane.agar@atlantichealth.orgMore trials in Morristown
- Rutgers New Jersey Medical School · Piscataway, NJ 08854More trials in Piscataway
- AtlantiCare Regional Medical Center · Pomona, NJ 08240Jackie White · Study contact · 609-652-3550 · jmwhite@atlanticare.orgAlison Hallam · Study contact · 609-652-3550 · ahallam@atlanticare.orgHaitham Dib, MD · Principal investigatorMore trials in Pomona
NY
- Buffalo General · Buffalo, NY 14203Courtney Bishop · Study contact · 716-888-4859 · cabishop@buffalo.eduRobert Cimato, MD, PhD · Principal investigatorMore trials in Buffalo
- Weill Cornell Medicine · New York, NY 10021More trials in New York
- Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC · Poughkeepsie, NY 12601Tricia Landi · Study contact · 845-473-8675 · tricia.landi@nuvancehealth.orgMore trials in Poughkeepsie
- Nuvance Health - Vassar brothers Medical Center · Poughkeepsie, NY 12601Tricia Landi · Study contact · 845-473-8675 · tricia.landi@nuvancehealth.orgMore trials in Poughkeepsie
OH
- TriHealth Bethesda · Cincinnati, OH 45202More trials in Cincinnati
- University Hospitals Cleveland Medical Center · Cleveland, OH 44106More trials in Cleveland
- Cleveland Clinic Foundation · Cleveland, OH 44195Barbara Gus · Study contact · gusb@ccf.orgMore trials in Cleveland
- Ohio State University Wexner Medical Center · Columbus, OH 43210Maeve McLoughlin · Study contact · 6142924084 · maeve.mcloughlin@osumc.eduMore trials in Columbus
- OhioHealth Research Institute · Columbus, OH 43214Reem (Mimi) Bekheet · Study contact · reem.bekheet@ohiohealth.comMore trials in Columbus
- Mercy Health- St. Vincent Medical Center LLC · Toledo, OH 43608More trials in Toledo
OK
- Oklahoma Heart Institute · Tulsa, OK 74104Colene Holland son · Study contact · colene.hollandson@oklahomaheart.comMiriam Brooks · Study contact · miriam.brooks@oklahomaheart.comMore trials in Tulsa
- St. Francis Hospital - Tulsa · Tulsa, OK 74136Riley Pritzlaff · Study contact · 918-494-8500 · mdixon2@saintfrancis.comMore trials in Tulsa
OR
- Providence Heart & Vascular · Portland, OR 97225Sarah Jackson · Study contact · sarah.jackson3@providence.orgMore trials in Portland
PA
- Bryn Mawr Medical Specialists Association · Bryn Mawr, PA 19010Morgan Battiste · Study contact · mbattiste@bmmsa.comMore trials in Bryn Mawr
- UPMC Pinnacle Harrisburg · Harrisburg, PA 17110More trials in Harrisburg
- Penn State Hershey Medical City · Hershey, PA 17033Lisa Fox · Study contact · lfox5@pennstatehealth.psu.eduMore trials in Hershey
- Lancaster General Hospital · Lancaster, PA 17602More trials in Lancaster
- Penn Presbyterian Medical Center · Philadelphia, PA 19104-6061Katie Shoemaker · Study contact · katie.shoemaker@pennmedicine.upenn.eduMore trials in Philadelphia
- Hospital of the University of Pennsylvania · Philadelphia, PA 19104Emily Marvel · Study contact · emily.marvel@pennmedicine.upenn.eduMore trials in Philadelphia
- Thomas Jefferson University Hospital · Philadelphia, PA 19107Blaire Cain · Study contact · 484-756-0929 · blaire.cain@jefferson.eduSusan Joseph, MD · Principal investigatorMore trials in Philadelphia
- Temple University Hospital · Philadelphia, PA 19140Kriti Rawat · Study contact · kriti.rawat@temple.eduMore trials in Philadelphia
- Allegheny General Hospital · Pittsburgh, PA 15212Kelly Kuniak · Study contact · Kelly.kuniak4@ahn.orgMore trials in Pittsburgh
- University of Pittsburgh Medical Center · Pittsburgh, PA 15213Traci McGaha · Study contact · mcgahatl4@upmc.eduMore trials in Pittsburgh
- Tower Health Reading Hospital · Reading, PA 19611More trials in Reading
- WellSpan Health · York, PA 17403More trials in York
SC
- Prisma Health Upstate · Greenville, SC 29601Kenneth Alfieri · Study contact · 8644557793 · Kenneth.alfieri@prismahelath.orgMore trials in Greenville
- Bon Secours Upstate Cardiology · Greenville, SC 29607More trials in Greenville
SD
- North Central Heart · Sioux Falls, SD 57108Robin Farley · Study contact · rfarley@ncheart.comOvar Jonsson, MD, FACC · Principal investigatorMore trials in Sioux Falls
TN
- The Stern Cardiovascular Foundation · Germantown, TN 38138Kristen Page · Study contact · kristen.page@sterncardio.comKari Fondren · Study contact · kari.fondren@sterncardio.comMore trials in Germantown
TX
- Texas Cardiac Arrhythmia Research Foundation · Austin, TX 78705More trials in Austin
- Ascension Seton · Austin, TX 78723Sarah Benedict · Study contact · sarah.benedict@ascension.orgMore trials in Austin
- Austin Heart · Austin, TX 78756Mary Fraser · Study contact · Mary.Fraser@hcahealthcare.comMore trials in Austin
- Baylor Scott and White Research Institute · Dallas, TX 75204Tein Luu · Study contact · 2148651685 ext. 481685 · tein.luu@bswhealth.orgMore trials in Dallas
- HCA Medical City Dallas · Dallas, TX 75230More trials in Dallas
- Baylor Scott White- All Saints- Fort Worth · Fort Worth, TX 76104Felicity Vaughan · Study contact · 8179222575 · felicity.vaughan@bswhealth.orgMore trials in Fort Worth
- Medical City Fort Worth Hospital · Fort Worth, TX 76104Jessica Blades · Study contact · Jessica.Blades@HCAhealthcare.comBrenda Tapia · Study contact · Brenda.Tapia@HCAhealthcare.comMore trials in Fort Worth
- Baylor College of Medicine · Houston, TX 77030Stephen Harold · Study contact · harold@bcm.eduMore trials in Houston
- Houston Methodist · Houston, TX 77030Deborah Barr · Study contact · ddbarr@houstonmethodist.orgMore trials in Houston
- Memorial Hermann Texas Medical Center · Houston, TX 77030Lawana Self · Study contact · Lawana.self@uth.tmc.eduIsabella Lefebvre · Study contact · Isabella.n.candelaria@uth.tmc.eduMore trials in Houston
- Heart Rhythm Specialists · McKinney, TX 75070Emily Buchanan · Study contact · research@hrsmedical.comMore trials in McKinney
- Baylor Scott and White- The Heart Hospital- Plano · Plano, TX 75093More trials in Plano
- Baylor Scott and White Research Institute - Round Rock · Round Rock, TX 78665Catherine Lyman · Study contact · catherine.lyman@bswhealth.orgMore trials in Round Rock
- Methodist Hospital · San Antonio, TX 78229More trials in San Antonio
VA
- Bon Secours St. Mary's · Richmond, VA 23114Janet Barrett · Study contact · 804-794-6400| · janet_barrett@bshsi.orgLaVonne Smith, MD · Principal investigatorMore trials in Richmond
- Bon Secours St. Mary's · Richmond, VA 23226Janet Barrett · Study contact · 804-794-6400 · janet_barrett@bshsi.orgLaVone Smith, MD · Principal investigatorMore trials in Richmond
WA
- Swedish Medical Center · Seattle, WA 98122Michelle Garcia · Study contact · michelle.garcia@swedish.orgMore trials in Seattle
- Peace Health · Vancouver, WA 98664Nancy Fitch · Study contact · nfitch@peacehealth.orgMore trials in Vancouver