Recruiting

CCM

Sponsor:

Impulse Dynamics

Code:

NCT05064709

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

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System

OPTIMIZER™ Smart Mini System

Study Details

Brief 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%.

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

Study ID

NCT05064709

Start date

Feb 3, 2022

Status verified date

Jun, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Feb 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CCM Group (CCM ON)

CCM therapy will be turned on in 2/3 of the subjects for the entire duration of the study.

sham comparator: Sham Group (CCM OFF)

CCM therapy will be turned off in 1/3 of the subjects for the first 18 months of the study. After 18 months, CCM therapy will be turned on for the rest of the study duration.

Interventions

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.

Primary outcome measure

  • Part 1 Efficacy Endpoint - Change in 6-minute walk distance (6MWD) from baseline to 6 months. [ Time Frame: 6 months ]
  • Part 1 Efficacy Endpoint - Change in the health status from baseline to 6 months as assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS). [ Time Frame: 6 months ]
  • Part 1 Safety Endpoint - The incidence of Optimizer device- or procedure-related complications within the first 12 months after implant [ Time Frame: 12 months ]
  • Part 2 Endpoint - The hierarchical composite of mortality, morbidity, and health status outcomes (KCCQ CSS). [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Gary Cranke

(856) 642-9933aimhigher@impulsedynamics.com

Locations

Grandview Medical Group Research, LLC

Recruiting

Birmingham, Alabama, United States, 35243

Contacts

Lauren Bryant

2059717553lauren.bryant@grandviewhealth.com

CardioVascular Associates of Mesa

Recruiting

Mesa, Arizona, United States, 85206

Contacts

Adam Gitkin

4806415400agitkin@cvam.com

Chan Heart Rhythm Institute

Recruiting

Mesa, Arizona, United States, 85206

Contacts

Olivia Rivera

olivia@chanheartrhythm.com

Southwest Cardiovascular Associates

Recruiting

Mesa, Arizona, United States, 85208

Contacts

Kim Helgeson

4809454343khelgeson@swcva.com

Arizona Heart Rhythm

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Brandon Buscaglia

bbuscaglia@azheartrhythm.com

Cardiovascular Consultants, Ltd

Recruiting

Phoenix, Arizona, United States, 85032

Contacts

Helen Foughi

hfoughi@insightmedr.com

HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Rachel Hultman

rhultman@honorhealth.com

Pima Heart and Vascular

Recruiting

Tuscon, Arizona, United States, 85712

Contacts

Monica Varela

5203294139monica.varela@pimaheartandvascular.com

John Muir Health

Recruiting

Concord, California, United States, 94520

Contacts

Rita Trachuk

rita.trachuk@johnmuirhealth.com

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Kendell Oliver

k4oliver@health.ucsd.edu

USC Keck School of Medicine

Recruiting

Los Angeles, California, United States, 90033

Contacts

Melissa Ramos

melissa.ramos@med.usc.edu

Silvia Perez

silvia.perez@med.usc.edu

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Goran Stankovic

goran.stankovic@cshs.org

Valley Clinical Trials- Northridge

Recruiting

Northridge, California, United States, 91325

Contacts

Haydee Gutierrez

haydee@valleyclinicaltrials.com

Sequoia Hospital

Recruiting

Redwood City, California, United States, 94062

Contacts

Juanita Fujii

juanita.fujii@commonspirit.org

Nuvance Health - Danbury Hospital

Recruiting

Danbury, Connecticut, United States, 06810

Contacts

Tricia Landi

tricia.landi@nuvancehealth.org

Hartford Healthcare

Recruiting

Hartford, Connecticut, United States, 06103

Contacts

Jennifer Rossi

jennifer.rossi@hhchealth.org

HCA Florida JFK Hospital

Recruiting

Atlantis, Florida, United States, 33462

Contacts

Elizabeth Diebel

Elizabeth.Diebel@hcahealthcare.com

Nouvelle Clinical Research LLC

Recruiting

Cutler Bay, Florida, United States, 33189

Contacts

Alexander Cabrera

acabrera@nouvelleclinicalresearch.com

Nilda Cespedes

ncespedes@nouvelleclinicalresearch.com

Broward Health

Recruiting

Fort Lauderdale, Florida, United States, 33316

Contacts

Laura Hudson

lhudson@browardhealth.org

Baptist Health South Florida

Recruiting

Miami, Florida, United States, 33176

Contacts

Jetsenea Coto

7865962421jetseneac@baptisthealth.net

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Contacts

Chanti Garvey

chantie.garvey@adventhealth.com

Revival Clinical Research

Recruiting

Orlando, Florida, United States, 32807

Contacts

Joseniesse Figueroa

jfigueroa@revivalclinical.com

Cleveland Clinic Foundation - Florida Weston Hospital

Recruiting

Weston, Florida, United States, 33326

Contacts

Maria Mejia Gomez

MEJIAGM@ccf.org

Ascension Medical Group St. Vincent

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Sabrina Rotondo

sabrina.rotondo@ascension.org

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Trisha Elliott

trisha-elliott@uiowa.edu

MercyOne Iowa Heart

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Cayla Garner

cayla.barnhart@commonspirit.org

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Quratulain (Annie) Mushtaq

9139456488qmushtaq@kumc.edu

Kansas City Cardiac Arrhythmia Research LLC

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Donita Atkins

donita.atkins@hcahealthcare.com

Jenny Bush

jennifer.bush2@hcahealthcare.com

Baptist Health Lexington

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Kristie Schneider

8592606429kschneid@bhsi.com

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Chinemerem Nwokemodo-Ihejirika

cnwokemodo-ihejirika@mgh.harvard.edu

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48113

Contacts

Kirsta Bray

kibray@med.umich.edu

Principal Investigator:

Thomas Crawford, MD

Henry Ford St. John Hospital

Recruiting

Detroit, Michigan, United States, 48236

Contacts

Renee Bess

renee.bess@ascension.org

Ascension Providence Hospital

Recruiting

Southfield, Michigan, United States, 48075

Contacts

Candice Edillo

candice.edillo@ascension.org

Trinity health- Michigan Heart

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Autumn Howe

ahowe@michiganheart.com

Minneapolis Heart Institute at Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Efrah Hussein

612-863-0666jessica.whelan@allina.com

St. Louis Heart and Vascular

Recruiting

Bridgeton, Missouri, United States, 63044

Contacts

Paige Brown

3147410911pbrown@slhv.com

St. Lukes Hospital Kansas City (Mid America Heart Institute)

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Amanda Huffman

ahuffman@saint-lukes.org

Bryan Heart

Recruiting

Lincoln, Nebraska, United States, 68506

Contacts

Nicci Thompson

nicci.thompson@bryanheart.com

Our Lady of Lourdes

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Marisa Brown

8563551226mbrown3@virtua.org

Cooper Hospital- Cardiovascular Associates of Delaware Valley

Recruiting

Haddon Heights, New Jersey, United States, 08035

Contacts

Erin Siderio

8565822000esiderio@hearthousenj.com

Atlantic Health System- Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Diane Agar

9739714205diane.agar@atlantichealth.org

AtlantiCare Regional Medical Center

Recruiting

Pomona, New Jersey, United States, 08240

Contacts

Jackie White

609-652-3550jmwhite@atlanticare.org

Alison Hallam

609-652-3550ahallam@atlanticare.org

Principal Investigator:

Haitham Dib, MD

Buffalo General

Recruiting

Buffalo, New York, United States, 14203

Contacts

Courtney Bishop

716-888-4859cabishop@buffalo.edu

Principal Investigator:

Robert Cimato, MD, PhD

Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC

Recruiting

Poughkeepsie, New York, United States, 12601

Contacts

Tricia Landi

845-473-8675tricia.landi@nuvancehealth.org

Nuvance Health - Vassar brothers Medical Center

Recruiting

Poughkeepsie, New York, United States, 12601

Contacts

Tricia Landi

845-473-8675tricia.landi@nuvancehealth.org

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Barbara Gus

gusb@ccf.org

Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Maeve McLoughlin

6142924084maeve.mcloughlin@osumc.edu

OhioHealth Research Institute

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Reem (Mimi) Bekheet

reem.bekheet@ohiohealth.com

Oklahoma Heart Institute

Recruiting

Tulsa, Oklahoma, United States, 74104

Contacts

Colene Holland son

colene.hollandson@oklahomaheart.com

Miriam Brooks

miriam.brooks@oklahomaheart.com

St. Francis Hospital - Tulsa

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Riley Pritzlaff

918-494-8500mdixon2@saintfrancis.com

Providence Heart & Vascular

Recruiting

Portland, Oregon, United States, 97225

Contacts

Sarah Jackson

sarah.jackson3@providence.org

Bryn Mawr Medical Specialists Association

Recruiting

Bryn Mawr, Pennsylvania, United States, 19010

Contacts

Morgan Battiste

mbattiste@bmmsa.com

Penn State Hershey Medical City

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Lisa Fox

lfox5@pennstatehealth.psu.edu

Penn Presbyterian Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104-6061

Contacts

Katie Shoemaker

katie.shoemaker@pennmedicine.upenn.edu

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Emily Marvel

emily.marvel@pennmedicine.upenn.edu

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Blaire Cain

484-756-0929blaire.cain@jefferson.edu

Principal Investigator:

Susan Joseph, MD

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Kriti Rawat

kriti.rawat@temple.edu

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Kelly Kuniak

Kelly.kuniak4@ahn.org

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Traci McGaha

mcgahatl4@upmc.edu

Prisma Health Upstate

Recruiting

Greenville, South Carolina, United States, 29601

Contacts

Kenneth Alfieri

8644557793Kenneth.alfieri@prismahelath.org

North Central Heart

Recruiting

Sioux Falls, South Dakota, United States, 57108

Contacts

Robin Farley

rfarley@ncheart.com

Principal Investigator:

Ovar Jonsson, MD, FACC

The Stern Cardiovascular Foundation

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Kristen Page

kristen.page@sterncardio.com

Kari Fondren

kari.fondren@sterncardio.com

Ascension Seton

Recruiting

Austin, Texas, United States, 78723

Contacts

Sarah Benedict

sarah.benedict@ascension.org

Austin Heart

Recruiting

Austin, Texas, United States, 78756

Contacts

Mary Fraser

Mary.Fraser@hcahealthcare.com

Baylor Scott and White Research Institute

Recruiting

Dallas, Texas, United States, 75204

Contacts

Tein Luu

2148651685tein.luu@bswhealth.org

Baylor Scott White- All Saints- Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Felicity Vaughan

8179222575felicity.vaughan@bswhealth.org

Medical City Fort Worth Hospital

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Jessica Blades

Jessica.Blades@HCAhealthcare.com

Brenda Tapia

Brenda.Tapia@HCAhealthcare.com

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Stephen Harold

harold@bcm.edu

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Deborah Barr

ddbarr@houstonmethodist.org

Memorial Hermann Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Lawana Self

Lawana.self@uth.tmc.edu

Isabella Lefebvre

Isabella.n.candelaria@uth.tmc.edu

Heart Rhythm Specialists

Recruiting

McKinney, Texas, United States, 75070

Contacts

Emily Buchanan

research@hrsmedical.com

Baylor Scott and White Research Institute - Round Rock

Recruiting

Round Rock, Texas, United States, 78665

Contacts

Catherine Lyman

catherine.lyman@bswhealth.org

Bon Secours St. Mary's

Recruiting

Richmond, Virginia, United States, 23114

Contacts

Janet Barrett

804-794-6400|janet_barrett@bshsi.org

Principal Investigator:

LaVonne Smith, MD

Bon Secours St. Mary's

Recruiting

Richmond, Virginia, United States, 23226

Contacts

Janet Barrett

804-794-6400janet_barrett@bshsi.org

Principal Investigator:

LaVone Smith, MD

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

Contacts

Michelle Garcia

michelle.garcia@swedish.org

Peace Health

Recruiting

Vancouver, Washington, United States, 98664

Contacts

Nancy Fitch

nfitch@peacehealth.org

More Information

Sponsor

Impulse Dynamics

Last update posted

Aug 6, 2026

Last verified

Jun, 2026

Keywords

  • HFpEF
  • Heart failure
  • CCM
  • CCM therapy
  • cardiac contractility modulation
  • symptomatic heart failure
  • left ventricular ejection fraction
  • LVEF
  • Optimizer
  • Optimizer Smart Mini
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by Impulse Dynamics on 2026-08-06.