Phase
Condition
Heart Failure
Hyponatremia
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 StatesSite Not Available
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 StatesSite Not Available
Honor Health
Scottsdale, Arizona 85258
United StatesSite Not Available
Pima Heart & Vascular
Tucson, Arizona 85719
United StatesActive - Recruiting
Pima Heart and Vascular Research Center
Tucson, Arizona 85712
United StatesSite Not Available
University of AZ - Sarver Heart Center
Tucson, Arizona 85724
United StatesActive - Recruiting
CardioVascular Associates of Mesa (CVAM)
Mesa 5304391, Arizona 5551752 85206
United StatesSite Not Available
Chan Heart Rhythm Institute (CHRI)
Mesa 5304391, Arizona 5551752 85206
United StatesSite Not Available
Southwest Cardiovascular Associates
Mesa 5304391, Arizona 5551752 85206
United StatesSite Not Available
Arizona Cardiovascular Research Center
Phoenix 5308655, Arizona 5551752 85016
United StatesSite Not Available
Banner University Medical Center
Phoenix 5308655, Arizona 5551752 85006
United StatesSite Not Available
Cardiovascular Society of Arizona
Phoenix 5308655, Arizona 5551752 85006
United StatesSite Not Available
Honor Health
Scottsdale 5313457, Arizona 5551752 85258
United StatesSite Not Available
Pima Heart and Vascular Research Center
Tucson 5318313, Arizona 5551752 85712
United StatesSite Not Available
University of AZ - Sarver Heart Center
Tucson 5318313, Arizona 5551752 85724
United StatesSite Not Available
Cardiovascular Institute of San Diego
Chula Vista, California 91911
United StatesSite Not Available
NorthBay Health, Heart and Vascular
Fairfield, California 94533
United StatesSite Not Available
Mid Valley Cardiology - Fresno
Fresno, California 93720
United StatesSite Not Available
South Orange County Cardiology Group
Laguna Hills, California 92653
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
University of Southern California - Keck School of Medicine
Los Angeles, California 90033
United StatesActive - Recruiting
Valley Clinical Trials
Northridge, California 91325
United StatesSite Not Available
Valley Clinical Trials
Pasadena, California 91105
United StatesSite Not Available
Cardiovascular Institute of San Diego
San Diego, California 92114
United StatesSite Not Available
Torrance Memorial Medical Center
Torrance, California 90505
United StatesSite Not Available
Cardiovascular Institute of San Diego
Chula Vista 5336899, California 5332921 91911
United StatesSite Not Available
NorthBay Health, Heart and Vascular
Fairfield 5347335, California 5332921 94533
United StatesSite Not Available
Mid Valley Cardiology - Fresno
Fresno 5350937, California 5332921 93720
United StatesSite Not Available
South Orange County Cardiology Group
Laguna Hills 5364306, California 5332921 92653
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
United StatesSite Not Available
University of Southern California - Keck School of Medicine
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
Valley Clinical Trials
Northridge 5377985, California 5332921 91325
United StatesSite Not Available
Valley Clinical Trials
Pasadena 5381396, California 5332921 91105
United StatesSite Not Available
Torrance Memorial Medical Center
Torrance 5403022, California 5332921 90505
United StatesSite Not Available
Aurora Denver Cardiology Associates
Aurora, Colorado 80012
United StatesSite Not Available
Aurora Denver Cardiology Associates
Aurora 5412347, Colorado 5417618 80012
United StatesSite Not Available
MedStar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesSite Not Available
Heart Rhythm Solutions
Davie, Florida 33328
United StatesSite Not Available
Florida Memorial Hospital
Jacksonville, Florida 32216
United StatesSite Not Available
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 StatesSite Not Available
Heart Rhythm Solutions
Davie 4152820, Florida 4155751 33328
United StatesSite Not Available
Florida Memorial Hospital
Jacksonville 4160021, Florida 4155751 32216
United StatesSite Not Available
Florida Cardiology
Orlando 4167147, Florida 4155751 32792
United StatesSite Not Available
Florida Heart Rhythm Specialist
Plantation 4168782, Florida 4155751 33324
United StatesSite Not Available
Piedmont Heart
Atlanta, Georgia 30309
United StatesSite Not Available
Redmond Regional Medical Center
Rome, Georgia 30165
United StatesSite Not Available
Piedmont Heart
Atlanta 4180439, Georgia 4197000 30309
United StatesSite Not Available
Redmond Regional Medical Center
Rome 4219762, Georgia 4197000 30165
United StatesSite Not Available
Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
United StatesSite Not Available
Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
United StatesSite Not Available
OSF Healthcare Cardiovascular Institute
Peoria, Illinois 61614
United StatesSite Not Available
OSF HealthCare Cardiovascular Institute
Rockford, Illinois 61107
United StatesSite Not Available
OSF Healthcare Cardiovascular Institute
Urbana, Illinois 61801
United StatesSite Not Available
Advocate Illinois Masonic Medical Center
Chicago 4887398, Illinois 4896861 60657
United StatesSite Not Available
Advocate Good Samaritan Hospital
Downers Grove 4890119, Illinois 4896861 60515
United StatesSite Not Available
OSF Healthcare Cardiovascular Institute
Peoria 4905687, Illinois 4896861 61614
United StatesSite Not Available
OSF HealthCare Cardiovascular Institute
Rockford 4907959, Illinois 4896861 61107
United StatesSite Not Available
OSF Healthcare Cardiovascular Institute
Urbana 4914570, Illinois 4896861 61801
United StatesSite Not Available
Ascension St. Vincent
Indianapolis, Indiana 46260
United StatesActive - Recruiting
Franciscan Physician Network
Indianapolis, Indiana 46237
United StatesSite Not Available
Community Healthcare System
Munster, Indiana 46321
United StatesSite Not Available
Ascension St. Vincent
Indianapolis 4259418, Indiana 4921868 46260
United StatesSite Not Available
Franciscan Physician Network
Indianapolis 4259418, Indiana 4921868 46237
United StatesSite Not Available
Community Healthcare System
Munster 4924014, Indiana 4921868 46321
United StatesSite Not Available
Baptist Lexington
Lexington, Kentucky 40503
United StatesActive - Recruiting
University of Kentucky - Gill Heart & Vascular Institute Clinical Research
Lexington, Kentucky 40536
United StatesSite Not Available
Baptist Lexington
Lexington 4297983, Kentucky 6254925 40503
United StatesSite Not Available
University of Kentucky - Gill Heart & Vascular Institute Clinical Research
Lexington 4297983, Kentucky 6254925 40536
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02241
United StatesSite Not Available
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02241
United StatesSite Not Available
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 StatesSite Not Available
St. Joseph Mercy Oakland
Pontiac, Michigan 48341
United StatesSite Not Available
Ascension Providence Rochester
Rochester, Michigan 48307
United StatesSite Not Available
Downriver Heart and Vascular
Southgate, Michigan 48195
United StatesSite Not Available
Trinity Health Michigan Heart
Ypsilanti, Michigan 48197
United StatesSite Not Available
Ascension Providence Park Hospital
Novi 5004062, Michigan 5001836 38374
United StatesSite Not Available
St. Joseph Mercy Oakland
Pontiac 5006166, Michigan 5001836 48341
United StatesSite Not Available
Downriver Heart and Vascular
Southgate 5010646, Michigan 5001836 48195
United StatesSite Not Available
Trinity Health Michigan Heart
Ypsilanti 5015688, Michigan 5001836 48197
United StatesSite Not Available
Minneapolis Heart Institute Foundation - Allina
Minneapolis, Minnesota 55407
United StatesSite Not Available
Minneapolis Heart Institute Foundation - Allina
Minneapolis 5037649, Minnesota 5037779 55407
United StatesSite Not Available
St. Louis Heart and Vascular
Bridgeton, Missouri 63044
United StatesSite Not Available
St. Louis Heart and Vascular
Bridgeton 4378391, Missouri 4398678 63044
United StatesSite Not Available
Logan Health
Kalispell, Montana 59901
United StatesSite Not Available
Logan Health
Kalispell 5660340, Montana 5667009 59901
United StatesSite Not Available
Our Lady of Lourdes
Camden, New Jersey 08103
United StatesSite Not Available
Cooper Hospital
Haddon Heights, New Jersey 08035
United StatesSite Not Available
Virtua Health - Our Lady of Lourdes
Marlton, New Jersey 08053
United StatesSite Not Available
Morristown Medical Center
Morristown, New Jersey 07960
United StatesSite Not Available
Jersey Shore University Medical Center
Neptune, New Jersey 07753
United StatesSite Not Available
Rutgers Medical School
Newark, New Jersey 07719
United StatesSite Not Available
Valley Hospital
Ridgewood, New Jersey 07450
United StatesSite Not Available
Cooper Hospital
Haddon Heights 4502093, New Jersey 5101760 08035
United StatesSite Not Available
Virtua Health - Our Lady of Lourdes
Marlton 4502911, New Jersey 5101760 08053
United StatesSite Not Available
Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960
United StatesSite Not Available
Rutgers Medical School
Newark 5101798, New Jersey 5101760 07719
United StatesSite Not Available
Valley Hospital
Ridgewood 5103269, New Jersey 5101760 07450
United StatesSite Not Available
Mount Sinai Morningside
New York, New York 10025
United StatesSite Not Available
Mount Sinai Morningside
New York 5128581, New York 5128638 10025
United StatesSite Not Available
Mission Health
Asheville, North Carolina 28801
United StatesSite Not Available
Atrium Health
Charlotte, North Carolina 28204
United StatesSite Not Available
NC Heart and Vascular Research
Raleigh, North Carolina 27607
United StatesSite Not Available
Mission Health
Asheville 4453066, North Carolina 4482348 28801
United StatesSite Not Available
Atrium Health
Charlotte 4460243, North Carolina 4482348 28204
United StatesSite Not Available
NC Heart and Vascular Research
Raleigh 4487042, North Carolina 4482348 27607
United StatesSite Not Available
TriHealth Hatton
Cincinnati, Ohio 45242
United StatesSite Not Available
University Hospitals of Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Mount Carmel Research institute
Columbus, Ohio 43213
United StatesCompleted
The Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Regional Cardiac Arrythmia Inc.
Steubenville, Ohio 43952
United StatesSite Not Available
Mercy Health - St. Vincent Medical Center
Toledo, Ohio 43608
United StatesActive - Recruiting
ProMedica Health Systems
Toledo, Ohio 43606
United StatesSite Not Available
TriHealth Hatton
Cincinnati 4508722, Ohio 5165418 45242
United StatesSite Not Available
University Hospitals of Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
Mount Carmel Research institute
Columbus 4509177, Ohio 5165418 43213
United StatesSite Not Available
The Ohio State University
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
Regional Cardiac Arrythmia Inc.
Steubenville 5173048, Ohio 5165418 43952
United StatesSite Not Available
Mercy Health - St. Vincent Medical Center
Toledo 5174035, Ohio 5165418 43608
United StatesSite Not Available
ProMedica Health Systems
Toledo 5174035, Ohio 5165418 43606
United StatesSite Not Available
Oklahoma Heart Hospital
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
Oklahoma Heart Hospital
Oklahoma City 4544349, Oklahoma 4544379 73120
United StatesSite Not Available
Abington Memorial Hospital
Abington, Pennsylvania 19001
United StatesSite Not Available
St. Luke's University Health Network
Allentown, Pennsylvania 18104
United StatesSite Not Available
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
United StatesSite Not Available
UPMC Pinnacle Health
Harrisburg, Pennsylvania 17011
United StatesSite Not Available
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
Penn Medicine Lancaster General Hospital
Lancaster, Pennsylvania 17602
United StatesSite Not Available
Albert Einstein Medical Center
Philadelphia, Pennsylvania 19141
United StatesActive - Recruiting
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania 19067
United StatesSite Not Available
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 StatesSite Not Available
Reading Hospital
Reading, Pennsylvania 19611
United StatesActive - Recruiting
Reading Hospital | Tower Health
Reading, Pennsylvania 19611
United StatesSite Not Available
Cardiovascular Consultants of Philadelphia
Yardley, Pennsylvania 19067
United StatesSite Not Available
St. Luke's University Health Network
Allentown 5178127, Pennsylvania 6254927 18104
United StatesSite Not Available
Bryn Mawr Hospital
Bryn Mawr 5182063, Pennsylvania 6254927 19010
United StatesSite Not Available
UPMC Pinnacle Health
Harrisburg 5192726, Pennsylvania 6254927 17011
United StatesSite Not Available
Penn State Milton S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033
United StatesSite Not Available
Penn Medicine Lancaster General Hospital
Lancaster 5197079, Pennsylvania 6254927 17602
United StatesSite Not Available
Cardiology Consultants of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19067
United StatesSite Not Available
Einstein Medical Center
Philadelphia 4560349, Pennsylvania 6254927 19141
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Penn Presybyterian Medical Center
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Temple University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19140
United StatesSite Not Available
Allegheny General Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15212
United StatesSite Not Available
UPMC Heart and Vascular Institute
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
Reading Hospital
Reading 5207728, Pennsylvania 6254927 19611
United StatesSite Not Available
Cardiovascular Consultants of Philadelphia
Yardley 5220281, Pennsylvania 6254927 19067
United StatesSite Not Available
Texas Cardiac Arrhythmia Research
Austin, Texas 78705
United StatesSite Not Available
VA North Texas Medical Center
Dallas, Texas 75216
United StatesSite Not Available
Texan Procedure Center
El Paso, Texas 79915
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesActive - Recruiting
UT Health - Memorial Hermann Hospital
Houston, Texas 77030
United StatesSite Not Available
Heart and Rhythm Institute of South Texas
San Antonio, Texas 78229
United StatesCompleted
UT Health San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
CHRISTUS Trinity Clinic Research
Tyler, Texas 75702
United StatesSite Not Available
Texas Cardiac Arrhythmia Research
Austin 4671654, Texas 4736286 78705
United StatesSite Not Available
VA North Texas Medical Center
Dallas 4684888, Texas 4736286 75216
United StatesSite Not Available
Texan Procedure Center
El Paso 5520993, Texas 4736286 79915
United StatesSite Not Available
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
UT Health - Memorial Hermann Hospital
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Heart and Rhythm Institute of South Texas
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
UT Health San Antonio
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
CHRISTUS Trinity Clinic Research
Tyler 4738214, Texas 4736286 75702
United StatesSite Not Available
Centra Health - Lynchburg General Hospital
Lynchburg, Virginia 24501
United StatesSite Not Available
Centra Health- Lynchburg General Hospital
Lynchburg, Virginia 24501
United StatesActive - Recruiting
Bon Secours St. Mary's Hospital
Midlothian, Virginia 23114
United StatesSite Not Available
HCA Chippenham Hospital
Richmond, Virginia 23225
United StatesActive - Recruiting
Richmond VA Medical Center
Richmond, Virginia 23249
United StatesSite Not Available
Centra Health- Lynchburg General Hospital
Lynchburg 4771075, Virginia 6254928 24501
United StatesSite Not Available
Bon Secours St. Mary's Hospital
Midlothian 4772943, Virginia 6254928 23114
United StatesSite Not Available
HCA Chippenham Hospital
Richmond 4781708, Virginia 6254928 23225
United StatesSite Not Available
Richmond VA Medical Center
Richmond 4781708, Virginia 6254928 23249
United StatesSite Not Available
CAMC Clinical Trials Center
Charleston, West Virginia 25304
United StatesSite Not Available
Marshall Cardiology
Huntington, West Virginia 25701
United StatesSite Not Available
CAMC Clinical Trials Center
Charleston 4801859, West Virginia 4826850 25304
United StatesSite Not Available
Marshall Cardiology
Huntington 4809537, West Virginia 4826850 25701
United StatesSite Not Available
Aurora Research Institute
Milwaukee, Wisconsin 53215
United StatesSite Not Available
Aurora Research Institute
Milwaukee 5263045, Wisconsin 5279468 53215
United StatesSite Not Available

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