What this study is
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's being tested
- Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System
Intervention · DEVICE
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
Intervention · DEVICE
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 details
- Official title
- Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction
- Sponsor
- Impulse Dynamics
- 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
- Enrolling
- 1,500 people
- Starts
- 2022-02-03
- Est. completion
- 2029-02-01
- Design
- Quadruple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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)Except: 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (67)
65 openGrandview Medical Group Research, LLC
Birmingham, Alabama, United States
- Lauren Bryant · Contact2059717553lauren.bryant@grandviewhealth.com
RecruitingCardioVascular Associates of Mesa
Mesa, Arizona, United States
- Adam Gitkin · Contact4806415400 ext. 2107agitkin@cvam.com
RecruitingSouthwest Cardiovascular Associates
Mesa, Arizona, United States
- Kim Helgeson · Contact4809454343 ext. 244khelgeson@swcva.com
Recruiting- Recruiting
Pima Heart and Vascular
Tuscon, Arizona, United States
- Monica Varela · Contact5203294139monica.varela@pimaheartandvascular.com
RecruitingUniversity of California San Diego
La Jolla, California, United States
- Kendell Oliver · Contactk4oliver@health.ucsd.edu
RecruitingUSC Keck School of Medicine
Los Angeles, California, United States
- Melissa Ramos · Contactmelissa.ramos@med.usc.edu
- Silvia Perez · Contactsilvia.perez@med.usc.edu
RecruitingCedars Sinai Medical Center
Los Angeles, California, United States
- Goran Stankovic · Contactgoran.stankovic@cshs.org
RecruitingValley Clinical Trials- Northridge
Northridge, California, United States
- Haydee Gutierrez · Contacthaydee@valleyclinicaltrials.com
RecruitingSequoia Hospital
Redwood City, California, United States
- Juanita Fujii · Contactjuanita.fujii@commonspirit.org
RecruitingNuvance Health - Danbury Hospital
Danbury, Connecticut, United States
- Tricia Landi · Contacttricia.landi@nuvancehealth.org
RecruitingHartford Healthcare
Hartford, Connecticut, United States
- Jennifer Rossi · Contactjennifer.rossi@hhchealth.org
RecruitingNouvelle Clinical Research LLC
Cutler Bay, Florida, United States
- Alexander Cabrera · Contactacabrera@nouvelleclinicalresearch.com
- Nilda Cespedes · Contactncespedes@nouvelleclinicalresearch.com
RecruitingBaptist Health South Florida
Miami, Florida, United States
- Jetsenea Coto · Contact7865962421jetseneac@baptisthealth.net
RecruitingAdventHealth Orlando
Orlando, Florida, United States
- Chanti Garvey · Contactchantie.garvey@adventhealth.com
RecruitingClinical One Research
Orlando, Florida, United States
- Joseniesse Figueroa · Contactjfigueroa@revivalclinical.com
RecruitingCleveland Clinic Foundation - Florida Weston Hospital
Weston, Florida, United States
- Maria Mejia Gomez · ContactMEJIAGM@ccf.org
RecruitingNortheast Georgia Health System
Gainesville, Georgia, United States
- Donna Patrick · Contact678-989-5001donna.patrick@nghs.com
RecruitingAscension Medical Group St. Vincent
Indianapolis, Indiana, United States
- Sabrina Rotondo · Contactsabrina.rotondo@ascension.org
Recruiting- Recruiting
MercyOne Iowa Heart
West Des Moines, Iowa, United States
- Cayla Garner · Contactcayla.barnhart@commonspirit.org
RecruitingUniversity of Kansas Medical Center
Kansas City, Kansas, United States
- Quratulain (Annie) Mushtaq · Contact9139456488qmushtaq@kumc.edu
RecruitingBaptist Health Lexington
Lexington, Kentucky, United States
- Kristie Schneider · Contact8592606429kschneid@bhsi.com
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
- Chinemerem Nwokemodo-Ihejirika · Contactcnwokemodo-ihejirika@mgh.harvard.edu
RecruitingUniversity of Michigan
Ann Arbor, Michigan, United States
- Kirsta Bray · Contactkibray@med.umich.edu
- Thomas Crawford, MD · Principal investigator
RecruitingHenry Ford St. John Hospital
Detroit, Michigan, United States
- Renee Bess · Contactrenee.bess@ascension.org
RecruitingAscension Providence Hospital
Southfield, Michigan, United States
- Candice Edillo · Contactcandice.edillo@ascension.org
RecruitingTrinity health- Michigan Heart
Ypsilanti, Michigan, United States
- Autumn Howe · Contactahowe@michiganheart.com
RecruitingMinneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
- Efrah Hussein · Contact612-863-0666jessica.whelan@allina.com
RecruitingSt. Lukes Hospital Kansas City (Mid America Heart Institute)
Kansas City, Missouri, United States
- Amanda Huffman · Contactahuffman@saint-lukes.org
Recruiting- Recruiting
Our Lady of Lourdes
Camden, New Jersey, United States
- Marisa Brown · Contact8563551226mbrown3@virtua.org
RecruitingCooper Hospital- Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, United States
- Erin Siderio · Contact8565822000 ext. 5207esiderio@hearthousenj.com
RecruitingAtlantic Health System- Morristown Medical Center
Morristown, New Jersey, United States
- Diane Agar · Contact9739714205diane.agar@atlantichealth.org
RecruitingAtlantiCare Regional Medical Center
Pomona, New Jersey, United States
- Jackie White · Contact609-652-3550jmwhite@atlanticare.org
- Alison Hallam · Contact609-652-3550ahallam@atlanticare.org
- Haitham Dib, MD · Principal investigator
RecruitingBuffalo General
Buffalo, New York, United States
- Courtney Bishop · Contact716-888-4859cabishop@buffalo.edu
- Robert Cimato, MD, PhD · Principal investigator
RecruitingNuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, New York, United States
- Tricia Landi · Contact845-473-8675tricia.landi@nuvancehealth.org
Recruiting- Recruiting
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
- Maeve McLoughlin · Contact6142924084maeve.mcloughlin@osumc.edu
RecruitingOhioHealth Research Institute
Columbus, Ohio, United States
- Reem (Mimi) Bekheet · Contactreem.bekheet@ohiohealth.com
RecruitingOklahoma Heart Institute
Tulsa, Oklahoma, United States
- Colene Holland son · Contactcolene.hollandson@oklahomaheart.com
- Miriam Brooks · Contactmiriam.brooks@oklahomaheart.com
RecruitingSt. Francis Hospital - Tulsa
Tulsa, Oklahoma, United States
- Riley Pritzlaff · Contact918-502-1606rpritzlaff@saintfrancis.com
RecruitingProvidence Heart & Vascular
Portland, Oregon, United States
- Sarah Jackson · Contactsarah.jackson3@providence.org
RecruitingBryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania, United States
- Morgan Battiste · Contactmbattiste@bmmsa.com
RecruitingPenn State Hershey Medical City
Hershey, Pennsylvania, United States
- Lisa Fox · Contactlfox5@pennstatehealth.psu.edu
RecruitingPenn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
- Katie Shoemaker · Contactkatie.shoemaker@pennmedicine.upenn.edu
RecruitingHospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
- Emily Marvel · Contactemily.marvel@pennmedicine.upenn.edu
RecruitingThomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
- Blaire Cain · Contact484-756-0929blaire.cain@jefferson.edu
- Susan Joseph, MD · Principal investigator
RecruitingTemple University Hospital
Philadelphia, Pennsylvania, United States
- Kriti Rawat · Contactkriti.rawat@temple.edu
RecruitingAllegheny General Hospital
Pittsburgh, Pennsylvania, United States
- Kelly Kuniak · ContactKelly.kuniak4@ahn.org
RecruitingUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
- Traci McGaha · Contactmcgahatl4@upmc.edu
RecruitingPrisma Health Upstate
Greenville, South Carolina, United States
- Kenneth Alfieri · Contact8644557793Kenneth.alfieri@prismahelath.org
RecruitingNorth Central Heart
Sioux Falls, South Dakota, United States
- Robin Farley · Contactrfarley@ncheart.com
- Ovar Jonsson, MD, FACC · Principal investigator
RecruitingThe Stern Cardiovascular Foundation
Germantown, Tennessee, United States
- Kristen Page · Contactkristen.page@sterncardio.com
- Kari Fondren · Contactkari.fondren@sterncardio.com
Recruiting- Recruiting
- Recruiting
Baylor Scott and White Research Institute
Dallas, Texas, United States
- Tein Luu · Contact2148651685 ext. 481685tein.luu@bswhealth.org
RecruitingBaylor Scott White- All Saints- Fort Worth
Fort Worth, Texas, United States
- Felicity Vaughan · Contact8179222575felicity.vaughan@bswhealth.org
RecruitingMedical City Fort Worth Hospital
Fort Worth, Texas, United States
- Jessica Blades · ContactJessica.Blades@HCAhealthcare.com
- Brenda Tapia · ContactBrenda.Tapia@HCAhealthcare.com
Recruiting- Recruiting
- Recruiting
Memorial Hermann Texas Medical Center
Houston, Texas, United States
- Lawana Self · ContactLawana.self@uth.tmc.edu
- Isabella Lefebvre · ContactIsabella.n.candelaria@uth.tmc.edu
RecruitingBon Secours St. Mary's
Richmond, Virginia, United States
- Janet Barrett · Contact804-794-6400janet_barrett@bshsi.org
- LaVone Smith, MD · Principal investigator
RecruitingSwedish Medical Center
Seattle, Washington, United States
- Michelle Garcia · Contactmichelle.garcia@swedish.org
Recruiting- Recruiting
Catholic Medical Center
Manchester, New Hampshire, United States
WithdrawnRutgers New Jersey Medical School
Piscataway, New Jersey, United States
Withdrawn
Study team
Sponsor
Impulse Dynamics
Study ID CA_CP_340
Principal investigator
Javed Butler, MD, MPH, MBA
Baylor Scott and White Research Institute, Dallas, Texas
Principal investigator
Oussama Wazni, MD, MBA
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.