Phase
Condition
Hyponatremia
Heart Failure
Congestive Heart Failure
Treatment
OPTIMIZER Smart System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient provides written authorization and/or consent per institution andgeographical requirements
Male or non-pregnant female, aged 18 or older
Left ventricular ejection fraction of 25-45% (inclusive, per site assessment)
NYHA Class III heart failure symptoms
Stated willingness to comply with all study procedures and availability for theduration of the study
Patient has been treated with guideline-directed medical therapy
Exclusion
Exclusion Criteria:
Primary heart failure due to uncorrected mitral valve disease, or mitral valverepair or clip within 90 days of implant
IV inotropes, hemofiltration, or any form of positive inotropic support within 30days prior to implant
Myocardial infarction within 90 days prior to implant
Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days ofimplant
Prior heart transplant or ventricular assist device
Mechanical tricuspid valve
Receiving cardiac resynchronization therapy (CRT) or has a Class I indication forCRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
Participating in a cardiac investigational study at the same time
Patient is in a vulnerable population (such as significant mental disability,prisoner) that in the judgement of the PI impedes ability to provide informedconsent.
Study Design
Study Description
Connect with a study center
CardioVascular Associates of Mesa (CVAM)
Mesa, Arizona 85206
United StatesActive - Recruiting
Chan Heart Rhythm Institute (CHRI)
Mesa, Arizona 85206
United StatesActive - Recruiting
Southwest Cardiovascular Associates
Mesa, Arizona 85206
United StatesActive - Recruiting
Arizona Cardiovascular Research Center
Phoenix, Arizona 85016
United StatesActive - Recruiting
Banner University Medical Center
Phoenix, Arizona 85006
United StatesActive - Recruiting
Cardiovascular Society of Arizona
Phoenix, Arizona 85006
United StatesActive - Recruiting
Honor Health
Scottsdale, Arizona 85258
United StatesActive - Recruiting
Pima Heart & Vascular
Tucson, Arizona 85719
United StatesActive - Recruiting
Pima Heart and Vascular Research Center
Tucson, Arizona 85712
United StatesActive - Recruiting
University of AZ - Sarver Heart Center
Tucson, Arizona 85724
United StatesActive - Recruiting
Cardiovascular Institute of San Diego
Chula Vista, California 91911
United StatesActive - Recruiting
NorthBay Health, Heart and Vascular
Fairfield, California 94533
United StatesActive - Recruiting
Mid Valley Cardiology - Fresno
Fresno, California 93720
United StatesActive - Recruiting
South Orange County Cardiology Group
Laguna Hills, California 92653
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesActive - Recruiting
University of Southern California - Keck School of Medicine
Los Angeles, California 90033
United StatesActive - Recruiting
Valley Clinical Trials
Northridge, California 91325
United StatesActive - Recruiting
Valley Clinical Trials
Pasadena, California 91105
United StatesActive - Recruiting
Cardiovascular Institute of San Diego
San Diego, California 92114
United StatesSite Not Available
Torrance Memorial Medical Center
Torrance, California 90505
United StatesActive - Recruiting
Aurora Denver Cardiology Associates
Aurora, Colorado 80012
United StatesActive - Recruiting
MedStar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
Heart Rhythm Solutions
Davie, Florida 33328
United StatesSite Not Available
Florida Memorial Hospital
Jacksonville, Florida 32216
United StatesActive - Recruiting
Naples Heart Rhythm Specialists
Naples, Florida 34119
United StatesSite Not Available
Florida Cardiology
Orlando, Florida 32792
United StatesSite Not Available
Florida Heart Rhythm Specialist
Plantation, Florida 33324
United StatesActive - Recruiting
Piedmont Heart
Atlanta, Georgia 30309
United StatesCompleted
Redmond Regional Medical Center
Rome, Georgia 30165
United StatesActive - Recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
United StatesCompleted
Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
United StatesCompleted
OSF Healthcare Cardiovascular Institute
Peoria, Illinois 61614
United StatesActive - Recruiting
OSF HealthCare Cardiovascular Institute
Rockford, Illinois 61107
United StatesActive - Recruiting
OSF Healthcare Cardiovascular Institute
Urbana, Illinois 61801
United StatesActive - Recruiting
Ascension St. Vincent
Indianapolis, Indiana 46260
United StatesActive - Recruiting
Franciscan Physician Network
Indianapolis, Indiana 46237
United StatesActive - Recruiting
Community Healthcare System
Munster, Indiana 46321
United StatesActive - Recruiting
Baptist Lexington
Lexington, Kentucky 40503
United StatesActive - Recruiting
University of Kentucky - Gill Heart & Vascular Institute Clinical Research
Lexington, Kentucky 40536
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02241
United StatesActive - Recruiting
Ascension St. John Hospital
Detroit, Michigan 48236
United StatesSite Not Available
Sparrow Clinical Research Institute
Lansing, Michigan 48912
United StatesSite Not Available
Ascension Providence Park Hospital
Novi, Michigan 38374
United StatesActive - Recruiting
St. Joseph Mercy Oakland
Pontiac, Michigan 48341
United StatesCompleted
Ascension Providence Rochester
Rochester, Michigan 48307
United StatesSite Not Available
Downriver Heart and Vascular
Southgate, Michigan 48195
United StatesActive - Recruiting
Trinity Health Michigan Heart
Ypsilanti, Michigan 48197
United StatesActive - Recruiting
Minneapolis Heart Institute Foundation - Allina
Minneapolis, Minnesota 55407
United StatesActive - Recruiting
St. Louis Heart and Vascular
Bridgeton, Missouri 63044
United StatesActive - Recruiting
Logan Health
Kalispell, Montana 59901
United StatesActive - Recruiting
Our Lady of Lourdes
Camden, New Jersey 08103
United StatesSite Not Available
Cooper Hospital
Haddon Heights, New Jersey 08035
United StatesActive - Recruiting
Virtua Health - Our Lady of Lourdes
Marlton, New Jersey 08053
United StatesActive - Recruiting
Morristown Medical Center
Morristown, New Jersey 07960
United StatesActive - Recruiting
Jersey Shore University Medical Center
Neptune, New Jersey 07753
United StatesSite Not Available
Rutgers Medical School
Newark, New Jersey 07719
United StatesActive - Recruiting
Valley Hospital
Ridgewood, New Jersey 07450
United StatesActive - Recruiting
Mount Sinai Morningside
New York, New York 10025
United StatesActive - Recruiting
Mission Health
Asheville, North Carolina 28801
United StatesActive - Recruiting
Atrium Health
Charlotte, North Carolina 28204
United StatesActive - Recruiting
NC Heart and Vascular Research
Raleigh, North Carolina 27607
United StatesActive - Recruiting
TriHealth Hatton
Cincinnati, Ohio 45242
United StatesActive - Recruiting
University Hospitals of Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
Mount Carmel Research institute
Columbus, Ohio 43213
United StatesCompleted
The Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
Regional Cardiac Arrythmia Inc.
Steubenville, Ohio 43952
United StatesActive - Recruiting
Mercy Health - St. Vincent Medical Center
Toledo, Ohio 43608
United StatesActive - Recruiting
ProMedica Health Systems
Toledo, Ohio 43606
United StatesActive - Recruiting
Oklahoma Heart Hospital
Oklahoma City, Oklahoma 73120
United StatesActive - Recruiting
Abington Memorial Hospital
Abington, Pennsylvania 19001
United StatesSite Not Available
St. Luke's University Health Network
Allentown, Pennsylvania 18104
United StatesActive - Recruiting
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
United StatesActive - Recruiting
UPMC Pinnacle Health
Harrisburg, Pennsylvania 17011
United StatesActive - Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesActive - Recruiting
Penn Medicine Lancaster General Hospital
Lancaster, Pennsylvania 17602
United StatesActive - Recruiting
Albert Einstein Medical Center
Philadelphia, Pennsylvania 19141
United StatesActive - Recruiting
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania 19067
United StatesActive - Recruiting
Einstein Medical Center
Philadelphia, Pennsylvania 19141
United StatesActive - Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesCompleted
Penn Presybyterian Medical Center
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Reading Hospital
Reading, Pennsylvania 19611
United StatesActive - Recruiting
Reading Hospital | Tower Health
Reading, Pennsylvania 19611
United StatesActive - Recruiting
Cardiovascular Consultants of Philadelphia
Yardley, Pennsylvania 19067
United StatesActive - Recruiting
Texas Cardiac Arrhythmia Research
Austin, Texas 78705
United StatesActive - Recruiting
VA North Texas Medical Center
Dallas, Texas 75216
United StatesActive - Recruiting
Texan Procedure Center
El Paso, Texas 79915
United StatesActive - Recruiting
Baylor College of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
UT Health - Memorial Hermann Hospital
Houston, Texas 77030
United StatesActive - Recruiting
Heart and Rhythm Institute of South Texas
San Antonio, Texas 78229
United StatesCompleted
UT Health San Antonio
San Antonio, Texas 78229
United StatesActive - Recruiting
CHRISTUS Trinity Clinic Research
Tyler, Texas 75702
United StatesActive - Recruiting
Centra Health - Lynchburg General Hospital
Lynchburg, Virginia 24501
United StatesActive - Recruiting
Centra Health- Lynchburg General Hospital
Lynchburg, Virginia 24501
United StatesActive - Recruiting
Bon Secours St. Mary's Hospital
Midlothian, Virginia 23114
United StatesActive - Recruiting
HCA Chippenham Hospital
Richmond, Virginia 23225
United StatesActive - Recruiting
Richmond VA Medical Center
Richmond, Virginia 23249
United StatesActive - Recruiting
CAMC Clinical Trials Center
Charleston, West Virginia 25304
United StatesCompleted
Marshall Cardiology
Huntington, West Virginia 25701
United StatesActive - Recruiting
Aurora Research Institute
Milwaukee, Wisconsin 53215
United StatesActive - Recruiting
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