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 Genders
- 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, Arizona 85206
Mesa, Arizona 85206
Chan Heart Rhythm Institute (CHRI)
Mesa, Arizona 85206
Mesa, Arizona 85206
Southwest Cardiovascular Associates
Mesa, Arizona 85206
Mesa, Arizona 85206
Banner University Medical Center
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Cardiovascular Society of Arizona
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Arizona Cardiovascular Research Center
Phoenix, Arizona 85016
Phoenix, Arizona 85016
Honor Health
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Pima Heart and Vascular Research Center
Tucson, Arizona 85712
Tucson, Arizona 85712
University of AZ - Sarver Heart Center
Tucson, Arizona 85724
Tucson, Arizona 85724
Cardiovascular Institute of San Diego
Chula Vista, California 91911
Chula Vista, California 91911
NorthBay Health, Heart and Vascular
Fairfield, California 94533
Fairfield, California 94533
Mid Valley Cardiology - Fresno
Fresno, California 93720
Fresno, California 93720
University of Southern California - Keck School of Medicine
Los Angeles, California 90033
Los Angeles, California 90033
Cedars-Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
Valley Clinical Trials
Northridge, California 91325
Northridge, California 91325
Valley Clinical Trials
Pasadena, California 91105
Pasadena, California 91105
Torrance Memorial Medical Center
Torrance, California 90505
Torrance, California 90505
Aurora Denver Cardiology Associates
Aurora, Colorado 80012
Aurora, Colorado 80012
Florida Memorial Hospital
Jacksonville, Florida 32216
Jacksonville, Florida 32216
Florida Heart Rhythm Specialist
Plantation, Florida 33324
Plantation, Florida 33324
Redmond Regional Medical Center
Rome, Georgia 30165
Rome, Georgia 30165
OSF Healthcare Cardiovascular Institute
Peoria, Illinois 61614
Peoria, Illinois 61614
OSF HealthCare Cardiovascular Institute
Rockford, Illinois 61107
Rockford, Illinois 61107
OSF Healthcare Cardiovascular Institute
Urbana, Illinois 61801
Urbana, Illinois 61801
Franciscan Physician Network
Indianapolis, Indiana 46237
Indianapolis, Indiana 46237
Ascension St. Vincent
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
Community Healthcare System
Munster, Indiana 46321
Munster, Indiana 46321
Baptist Lexington
Lexington, Kentucky 40503
Lexington, Kentucky 40503
University of Kentucky - Gill Heart & Vascular Institute Clinical Research
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Massachusetts General Hospital
Boston, Massachusetts 02241
Boston, Massachusetts 02241
Ascension Providence Park Hospital
Novi, Michigan 38374
Novi, Michigan 38374
Downriver Heart and Vascular
Southgate, Michigan 48195
Southgate, Michigan 48195
Trinity Health Michigan Heart
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Minneapolis Heart Institute Foundation - Allina
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
St. Louis Heart and Vascular
Bridgeton, Missouri 63044
Bridgeton, Missouri 63044
Cooper Hospital
Haddon Heights, New Jersey 08035
Haddon Heights, New Jersey 08035
Virtua Health - Our Lady of Lourdes
Marlton, New Jersey 08053
Marlton, New Jersey 08053
Morristown Medical Center
Morristown, New Jersey 07960
Morristown, New Jersey 07960
Rutgers Medical School
Newark, New Jersey 07719
Newark, New Jersey 07719
Valley Hospital
Ridgewood, New Jersey 07450
Ridgewood, New Jersey 07450
Mount Sinai Morningside
New York, New York 10025
New York, New York 10025
Mission Health
Asheville, North Carolina 28801
Asheville, North Carolina 28801
Atrium Health
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
NC Heart and Vascular Research
Raleigh, North Carolina 27607
Raleigh, North Carolina 27607
TriHealth Hatton
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
University Hospitals of Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
The Ohio State University
Columbus, Ohio 43210
Columbus, Ohio 43210
Regional Cardiac Arrythmia Inc.
Steubenville, Ohio 43952
Steubenville, Ohio 43952
ProMedica Health Systems
Toledo, Ohio 43606
Toledo, Ohio 43606
Mercy Health - St. Vincent Medical Center
Toledo, Ohio 43608
Toledo, Ohio 43608
Oklahoma Heart Hospital
Oklahoma City, Oklahoma 73120
Oklahoma City, Oklahoma 73120
St. Luke's University Health Network
Allentown, Pennsylvania 18104
Allentown, Pennsylvania 18104
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
Bryn Mawr, Pennsylvania 19010
UPMC Pinnacle Health
Harrisburg, Pennsylvania 17011
Harrisburg, Pennsylvania 17011
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
Penn Medicine Lancaster General Hospital
Lancaster, Pennsylvania 17602
Lancaster, Pennsylvania 17602
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania 19067
Philadelphia, Pennsylvania 19067
Penn Presybyterian Medical Center
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Temple University Hospital
Philadelphia, Pennsylvania 19140
Philadelphia, Pennsylvania 19140
Einstein Medical Center
Philadelphia, Pennsylvania 19141
Philadelphia, Pennsylvania 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Reading Hospital
Reading, Pennsylvania 19611
Reading, Pennsylvania 19611
Cardiovascular Consultants of Philadelphia
Yardley, Pennsylvania 19067
Yardley, Pennsylvania 19067
Texas Cardiac Arrhythmia Research
Austin, Texas 78705
Austin, Texas 78705
VA North Texas Medical Center
Dallas, Texas 75216
Dallas, Texas 75216
Texan Procedure Center
El Paso, Texas 79915
El Paso, Texas 79915
UT Health - Memorial Hermann Hospital
Houston, Texas 77030
Houston, Texas 77030
UT Health San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
CHRISTUS Trinity Clinic Research
Tyler, Texas 75702
Tyler, Texas 75702
Centra Health- Lynchburg General Hospital
Lynchburg, Virginia 24501
Lynchburg, Virginia 24501
Bon Secours St. Mary's Hospital
Midlothian, Virginia 23114
Midlothian, Virginia 23114
HCA Chippenham Hospital
Richmond, Virginia 23225
Richmond, Virginia 23225
Richmond VA Medical Center
Richmond, Virginia 23249
Richmond, Virginia 23249
Marshall Cardiology
Huntington, West Virginia 25701
Huntington, West Virginia 25701
Aurora Research Institute
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 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.