Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
Purpose
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%
Condition
- Heart Failure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patient provides written authorization and/or consent per institution and geographical requirements 2. Male or non-pregnant female, aged 18 or older 3. Left ventricular ejection fraction of 25-45% (inclusive, per site assessment) 4. NYHA Class III heart failure symptoms 5. Stated willingness to comply with all study procedures and availability for the duration of the study 6. Patient has been treated with guideline-directed medical therapy
Exclusion Criteria
- Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant 2. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant 3. Myocardial infarction within 90 days prior to implant 4. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant 5. Prior heart transplant or ventricular assist device 6. Mechanical tricuspid valve 7. Receiving cardiac resynchronization therapy (CRT) or has a Class I indication for CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy 8. Participating in a cardiac investigational study at the same time 9. Patient is in a vulnerable population (such as significant mental disability, prisoner) that in the judgement of the PI impedes ability to provide informed consent.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Other
- Time Perspective
- Prospective
Recruiting Locations
CardioVascular Associates of Mesa (CVAM)
Mesa 5304391, Arizona 5551752 85206
Mesa 5304391, Arizona 5551752 85206
Chan Heart Rhythm Institute (CHRI)
Mesa 5304391, Arizona 5551752 85206
Mesa 5304391, Arizona 5551752 85206
Southwest Cardiovascular Associates
Mesa 5304391, Arizona 5551752 85206
Mesa 5304391, Arizona 5551752 85206
Banner University Medical Center
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85006
Cardiovascular Society of Arizona
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85006
Arizona Cardiovascular Research Center
Phoenix 5308655, Arizona 5551752 85016
Phoenix 5308655, Arizona 5551752 85016
Honor Health
Scottsdale 5313457, Arizona 5551752 85258
Scottsdale 5313457, Arizona 5551752 85258
Pima Heart and Vascular Research Center
Tucson 5318313, Arizona 5551752 85712
Tucson 5318313, Arizona 5551752 85712
University of AZ - Sarver Heart Center
Tucson 5318313, Arizona 5551752 85724
Tucson 5318313, Arizona 5551752 85724
Cardiovascular Institute of San Diego
Chula Vista 5336899, California 5332921 91911
Chula Vista 5336899, California 5332921 91911
NorthBay Health, Heart and Vascular
Fairfield 5347335, California 5332921 94533
Fairfield 5347335, California 5332921 94533
Mid Valley Cardiology - Fresno
Fresno 5350937, California 5332921 93720
Fresno 5350937, California 5332921 93720
University of Southern California - Keck School of Medicine
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
Los Angeles 5368361, California 5332921 90048
Valley Clinical Trials
Northridge 5377985, California 5332921 91325
Northridge 5377985, California 5332921 91325
Valley Clinical Trials
Pasadena 5381396, California 5332921 91105
Pasadena 5381396, California 5332921 91105
Torrance Memorial Medical Center
Torrance 5403022, California 5332921 90505
Torrance 5403022, California 5332921 90505
Aurora Denver Cardiology Associates
Aurora 5412347, Colorado 5417618 80012
Aurora 5412347, Colorado 5417618 80012
Florida Memorial Hospital
Jacksonville 4160021, Florida 4155751 32216
Jacksonville 4160021, Florida 4155751 32216
Florida Heart Rhythm Specialist
Plantation 4168782, Florida 4155751 33324
Plantation 4168782, Florida 4155751 33324
Redmond Regional Medical Center
Rome 4219762, Georgia 4197000 30165
Rome 4219762, Georgia 4197000 30165
OSF Healthcare Cardiovascular Institute
Peoria 4905687, Illinois 4896861 61614
Peoria 4905687, Illinois 4896861 61614
OSF HealthCare Cardiovascular Institute
Rockford 4907959, Illinois 4896861 61107
Rockford 4907959, Illinois 4896861 61107
OSF Healthcare Cardiovascular Institute
Urbana 4914570, Illinois 4896861 61801
Urbana 4914570, Illinois 4896861 61801
Franciscan Physician Network
Indianapolis 4259418, Indiana 4921868 46237
Indianapolis 4259418, Indiana 4921868 46237
Ascension St. Vincent
Indianapolis 4259418, Indiana 4921868 46260
Indianapolis 4259418, Indiana 4921868 46260
Baptist Lexington
Lexington 4297983, Kentucky 6254925 40503
Lexington 4297983, Kentucky 6254925 40503
University of Kentucky - Gill Heart & Vascular Institute Clinical Research
Lexington 4297983, Kentucky 6254925 40536
Lexington 4297983, Kentucky 6254925 40536
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02241
Boston 4930956, Massachusetts 6254926 02241
Ascension Providence Park Hospital
Novi 5004062, Michigan 5001836 38374
Novi 5004062, Michigan 5001836 38374
Downriver Heart and Vascular
Southgate 5010646, Michigan 5001836 48195
Southgate 5010646, Michigan 5001836 48195
Trinity Health Michigan Heart
Ypsilanti 5015688, Michigan 5001836 48197
Ypsilanti 5015688, Michigan 5001836 48197
Minneapolis Heart Institute Foundation - Allina
Minneapolis 5037649, Minnesota 5037779 55407
Minneapolis 5037649, Minnesota 5037779 55407
St. Louis Heart and Vascular
Bridgeton 4378391, Missouri 4398678 63044
Bridgeton 4378391, Missouri 4398678 63044
Logan Health
Kalispell 5660340, Montana 5667009 59901
Kalispell 5660340, Montana 5667009 59901
Cooper Hospital
Haddon Heights 4502093, New Jersey 5101760 08035
Haddon Heights 4502093, New Jersey 5101760 08035
Virtua Health - Our Lady of Lourdes
Marlton 4502911, New Jersey 5101760 08053
Marlton 4502911, New Jersey 5101760 08053
Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960
Morristown 5101427, New Jersey 5101760 07960
Rutgers Medical School
Newark 5101798, New Jersey 5101760 07719
Newark 5101798, New Jersey 5101760 07719
Valley Hospital
Ridgewood 5103269, New Jersey 5101760 07450
Ridgewood 5103269, New Jersey 5101760 07450
Mount Sinai Morningside
New York 5128581, New York 5128638 10025
New York 5128581, New York 5128638 10025
Mission Health
Asheville 4453066, North Carolina 4482348 28801
Asheville 4453066, North Carolina 4482348 28801
Atrium Health
Charlotte 4460243, North Carolina 4482348 28204
Charlotte 4460243, North Carolina 4482348 28204
NC Heart and Vascular Research
Raleigh 4487042, North Carolina 4482348 27607
Raleigh 4487042, North Carolina 4482348 27607
TriHealth Hatton
Cincinnati 4508722, Ohio 5165418 45242
Cincinnati 4508722, Ohio 5165418 45242
University Hospitals of Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
Cleveland 5150529, Ohio 5165418 44106
The Ohio State University
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
Regional Cardiac Arrythmia Inc.
Steubenville 5173048, Ohio 5165418 43952
Steubenville 5173048, Ohio 5165418 43952
Mercy Health - St. Vincent Medical Center
Toledo 5174035, Ohio 5165418 43608
Toledo 5174035, Ohio 5165418 43608
Oklahoma Heart Hospital
Oklahoma City 4544349, Oklahoma 4544379 73120
Oklahoma City 4544349, Oklahoma 4544379 73120
St. Luke's University Health Network
Allentown 5178127, Pennsylvania 6254927 18104
Allentown 5178127, Pennsylvania 6254927 18104
Bryn Mawr Hospital
Bryn Mawr 5182063, Pennsylvania 6254927 19010
Bryn Mawr 5182063, Pennsylvania 6254927 19010
UPMC Pinnacle Health
Harrisburg 5192726, Pennsylvania 6254927 17011
Harrisburg 5192726, Pennsylvania 6254927 17011
Penn State Milton S. Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033
Hershey 5193342, Pennsylvania 6254927 17033
Penn Medicine Lancaster General Hospital
Lancaster 5197079, Pennsylvania 6254927 17602
Lancaster 5197079, Pennsylvania 6254927 17602
Cardiology Consultants of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19067
Philadelphia 4560349, Pennsylvania 6254927 19067
Penn Presybyterian Medical Center
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Temple University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19140
Philadelphia 4560349, Pennsylvania 6254927 19140
Einstein Medical Center
Philadelphia 4560349, Pennsylvania 6254927 19141
Philadelphia 4560349, Pennsylvania 6254927 19141
Allegheny General Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15212
Pittsburgh 5206379, Pennsylvania 6254927 15212
UPMC Heart and Vascular Institute
Pittsburgh 5206379, Pennsylvania 6254927 15213
Pittsburgh 5206379, Pennsylvania 6254927 15213
Reading Hospital
Reading 5207728, Pennsylvania 6254927 19611
Reading 5207728, Pennsylvania 6254927 19611
Cardiovascular Consultants of Philadelphia
Yardley 5220281, Pennsylvania 6254927 19067
Yardley 5220281, Pennsylvania 6254927 19067
Texas Cardiac Arrhythmia Research
Austin 4671654, Texas 4736286 78705
Austin 4671654, Texas 4736286 78705
VA North Texas Medical Center
Dallas 4684888, Texas 4736286 75216
Dallas 4684888, Texas 4736286 75216
Texan Procedure Center
El Paso 5520993, Texas 4736286 79915
El Paso 5520993, Texas 4736286 79915
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
UT Health - Memorial Hermann Hospital
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
UT Health San Antonio
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
CHRISTUS Trinity Clinic Research
Tyler 4738214, Texas 4736286 75702
Tyler 4738214, Texas 4736286 75702
Centra Health- Lynchburg General Hospital
Lynchburg 4771075, Virginia 6254928 24501
Lynchburg 4771075, Virginia 6254928 24501
Bon Secours St. Mary's Hospital
Midlothian 4772943, Virginia 6254928 23114
Midlothian 4772943, Virginia 6254928 23114
HCA Chippenham Hospital
Richmond 4781708, Virginia 6254928 23225
Richmond 4781708, Virginia 6254928 23225
Richmond VA Medical Center
Richmond 4781708, Virginia 6254928 23249
Richmond 4781708, Virginia 6254928 23249
Marshall Cardiology
Huntington 4809537, West Virginia 4826850 25701
Huntington 4809537, West Virginia 4826850 25701
Aurora Research Institute
Milwaukee 5263045, Wisconsin 5279468 53215
Milwaukee 5263045, Wisconsin 5279468 53215
More Details
- NCT ID
- NCT03970343
- Status
- Recruiting
- Sponsor
- Impulse Dynamics
Detailed Description
The Impulse Dynamics OPTIMIZER Smart Pre-Market Application (PMA) clinical data confirmed that CCM therapy delivered with the Optimizer meaningfully improved health outcomes in patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45%. CCM has shown significant improvements in quality of life measures, with an average improvement of >11 points in MLHWFQ incremental to the improvement of a randomized control group with no device. Six minute hall walk and functional class also showed improvements in the PMA data. The post-approval study (PAS) protocol has been designed to evaluate long term safety and efficacy of the OPTIMIZER Smart in a real-world setting.