Phase
Condition
Heart Failure
Chest Pain
Hyponatremia
Treatment
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System
OPTIMIZER™ Smart Mini System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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. Heart failure hospitalization within 12 months prior to study consent OR anurgent heart failure visit requiring IV therapy within 6 months prior to studyconsent OR B. If there is no heart failure hospitalization within 12 months prior tostudy consent OR an urgent heart failure visit requiring IV therapy within 6 monthsprior to study consent, an elevated BMI-adjusted natriuretic peptide value must beachieved (Refer to Table 1 in Section 9.2.6)
Subjects must meet one of the following conditions:
Have stable, scheduled oral loop diuretic treatment (not just PRN) for aminimum of 30 days before providing study consent unless there is a documentedallergy or intolerance.
Eligibility for enrollment is maintained for patients on an SGLT2 inhibitorwithout prescribed concurrent standing loop diuretic therapy if investigatorsprovide instructions for a flexible PRN diuretic regimen (deemed appropriate bythe clinician in response to symptoms or weight gain) Note: Stable is definedas no more than a 100% increase or 50% decrease in dose within the last 30days. A one-time hold of diuretic dosing for 24 hours during the 30-day periodis allowed and not an exclusionary event.
Exclusion
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;
Exercise tolerance limited by a condition other than heart failure that, in theopinion of the investigator, contributes significantly to the primary symptoms ofshortness of breath and/or exercise intolerance;
Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
A KCCQ CCS score higher than 85;
Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy;
Unstable angina pectoris within 30 days prior to study consent;
Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30days prior to consent, in the hospital or an outpatient setting;
Receiving cardiac resynchronization therapy (CRT); NOTE: Subjects withactive/ongoing cardiac resynchronization therapy (CRT) implanted more than one yearago are eligible for inclusion if they are currently classified as NYHA class III orhigher.
Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or haveundergone cardiac surgery within 90 days or a PCI procedure within 30 days prior tostudy 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 interferewith the interpretation of study data;
Currently undergoing active chemotherapeutic and/or radiation treatment for canceror 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 in the investigator'sjudgement.
Study Design
Study Description
Connect with a study center
Grandview Medical Group Research, LLC
Birmingham, Alabama 35243
United StatesActive - Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
CardioVascular Associates of Mesa
Mesa, Arizona 85206
United StatesActive - Recruiting
Chan Heart Rhythm Institute
Mesa, Arizona 85206
United StatesActive - Recruiting
Southwest Cardiovascular Associates
Mesa, Arizona 85208
United StatesActive - Recruiting
Arizona Heart Rhythm
Phoenix, Arizona 85016
United StatesActive - Recruiting
Banner Health- Phoenix
Phoenix, Arizona 85006
United StatesSite Not Available
Cardiovascular Consultants, Ltd
Phoenix, Arizona 85032
United StatesActive - Recruiting
HonorHealth
Scottsdale, Arizona 85258
United StatesActive - Recruiting
Pima Heart and Vascular
Tucson, Arizona 85712
United StatesSite Not Available
Pima Heart and Vascular
Tuscon, Arizona 85712
United StatesActive - Recruiting
John Muir Health
Concord, California 94520
United StatesActive - Recruiting
Northbay Heart and Vascular
Fairfield, California 94533
United StatesSite Not Available
University of California San Diego
La Jolla, California 92093
United StatesActive - Recruiting
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesActive - Recruiting
USC Keck School of Medicine
Los Angeles, California 90033
United StatesActive - Recruiting
Valley Clinical Trials Pasadena
Northridge, California 91325
United StatesSite Not Available
Valley Clinical Trials- Foothill Cardiology
Northridge, California 91325
United StatesActive - Recruiting
Valley Clinical Trials- Northridge
Northridge, California 91325
United StatesActive - Recruiting
Sequoia Hospital
Redwood City, California 94062
United StatesActive - Recruiting
University of California Davis Health
Sacramento, California 95817
United StatesSite Not Available
University of California, San Francisco
San Francisco, California 94143
United StatesActive - Recruiting
Hartford Healthcare
Hartford, Connecticut 06103
United StatesActive - Recruiting
Nuvance Health
Wilton, Connecticut 06897
United StatesActive - Recruiting
HCA Florida JFK Hospital
Atlantis, Florida 33462
United StatesActive - Recruiting
Nouvelle Clinical Research LLC
Cutler Bay, Florida 33189
United StatesActive - Recruiting
Broward Health
Fort Lauderdale, Florida 33316
United StatesActive - Recruiting
Holy Cross Hospital
Fort Lauderdale, Florida 33308
United StatesSite Not Available
Memorial Healthcare System
Hollywood, Florida 33021
United StatesSite Not Available
Baptist Health South Florida
Miami, Florida 33176
United StatesActive - Recruiting
NCA Research Institute - Florida
Naples, Florida 34102
United StatesSite Not Available
AdventHealth Orlando
Orlando, Florida 32803
United StatesActive - Recruiting
Revival Clinical Research
Orlando, Florida 32807
United StatesActive - Recruiting
Tallahassee Research Institute
Tallahassee, Florida 32308
United StatesActive - Recruiting
Cleveland Clinic Foundation - Florida Weston Hospital
Weston, Florida 33326
United StatesActive - Recruiting
Piedmont Healthcare
Atlanta, Georgia 30309
United StatesSite Not Available
WellStar Health System, Inc
Marietta, Georgia 30062
United StatesActive - Recruiting
Ascension Medical Group St. Vincent
Indianapolis, Indiana 46260
United StatesActive - Recruiting
Franciscan Health Indianapolis
Indianapolis, Indiana 46237
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52242
United StatesActive - Recruiting
MercyOne Iowa Heart
West Des Moines, Iowa 50266
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas 66211
United StatesActive - Recruiting
Baptist Health Lexington
Lexington, Kentucky 40503
United StatesActive - Recruiting
University of Kentucky Research Foundation
Lexington, Kentucky 40506
United StatesActive - Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Ascension St. John
Detroit, Michigan 48236
United StatesActive - Recruiting
Ascension Providence Hospital
Southfield, Michigan 48075
United StatesActive - Recruiting
Trinity health- Michigan Heart
Ypsilanti, Michigan 48197
United StatesActive - Recruiting
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota 55407
United StatesActive - Recruiting
North Mississippi Medical Center
Tupelo, Mississippi 38801
United StatesSite Not Available
St. Louis Heart and Vascular
Bridgeton, Missouri 63044
United StatesActive - Recruiting
St. Luke's Hospital
Chesterfield, Missouri 63017
United StatesSite Not Available
St. Luke's Hospital
Chesterfield, Missouri 63017
United StatesActive - Recruiting
St. Lukes Hospital Kansas City (Mid America Heart Institute)
Kansas City, Missouri 64111
United StatesActive - Recruiting
Bryan Heart
Lincoln, Nebraska 68506
United StatesActive - Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68198-5331
United StatesActive - Recruiting
Catholic Medical Center
Manchester, New Hampshire 03102
United StatesActive - Recruiting
Our Lady of Lourdes
Camden, New Jersey 08103
United StatesActive - Recruiting
Hackensack University Medical Center
Edison, New Jersey 08837
United StatesSite Not Available
Jersey Shore University Medical Center
Edison, New Jersey 08837
United StatesSite Not Available
Cooper Hospital- Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey 08035
United StatesActive - Recruiting
Atlantic Health System- Morristown Medical Center
Morristown, New Jersey 07960
United StatesActive - Recruiting
Rutgers New Jersey Medical School
Piscataway, New Jersey 08854
United StatesSite Not Available
Weill Cornell Medicine
New York, New York 10021
United StatesSite Not Available
Sanger Heart and Vascular
Charlotte, North Carolina 28203
United StatesSite Not Available
TriHealth Bethesda
Cincinnati, Ohio 45202
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United StatesActive - Recruiting
OhioHealth Research Institute
Columbus, Ohio 43214
United StatesActive - Recruiting
Mercy Health- St. Vincent Medical Center LLC
Toledo, Ohio 43608
United StatesSite Not Available
Oklahoma Heart Institute
Tulsa, Oklahoma 74104
United StatesActive - Recruiting
St. Francis Hospital - Tulsa
Tulsa, Oklahoma 74136
United StatesActive - Recruiting
Providence Heart & Vascular
Portland, Oregon 97225
United StatesActive - Recruiting
Bryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania 19010
United StatesActive - Recruiting
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania 17110
United StatesSite Not Available
Penn State Hershey Medical City
Hershey, Pennsylvania 17033
United StatesActive - Recruiting
Lancaster General Hospital
Lancaster, Pennsylvania 17602
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104-6061
United StatesActive - Recruiting
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Tower Health Reading Hospital
Reading, Pennsylvania 19611
United StatesSite Not Available
WellSpan Health
York, Pennsylvania 17403
United StatesActive - Recruiting
Prisma Health Upstate
Greenville, South Carolina 29601
United StatesActive - Recruiting
The Stern Cardiovascular Foundation
Germantown, Tennessee 38138
United StatesActive - Recruiting
Ascension Seton
Austin, Texas 78723
United StatesActive - Recruiting
Austin Heart
Austin, Texas 78756
United StatesActive - Recruiting
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78705
United StatesSite Not Available
Baylor Scott and White Research Institute
Dallas, Texas 75204
United StatesActive - Recruiting
HCA Medical City Dallas
Dallas, Texas 75230
United StatesSite Not Available
Baylor Scott White- All Saints- Fort Worth
Fort Worth, Texas 76104
United StatesActive - Recruiting
Medical City Fort Worth Hospital
Fort Worth, Texas 76104
United StatesActive - Recruiting
Baylor College of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
Houston Methodist
Houston, Texas 77030
United StatesActive - Recruiting
Memorial Hermann Texas Medical Center
Houston, Texas 77030
United StatesActive - Recruiting
Heart Rhythm Specialists
McKinney, Texas 75070
United StatesActive - Recruiting
Baylor Scott and White- The Heart Hospital- Plano
Plano, Texas 75093
United StatesSite Not Available
Baylor Scott and White Research Institute - Round Rock
Round Rock, Texas 78665
United StatesActive - Recruiting
Methodist Hospital
San Antonio, Texas 78229
United StatesActive - Recruiting
Swedish Medical Center
Seattle, Washington 98122
United StatesActive - Recruiting
Peace Health
Vancouver, Washington 98664
United StatesActive - Recruiting
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