Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
- Conditions
- Heart Failure
- Registration Number
- NCT03970343
- Lead Sponsor
- Impulse Dynamics
- Brief Summary
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%
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 620
- Patient provides written authorization and/or consent per institution and geographical 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 the duration of the study
- Patient has been treated with guideline-directed medical therapy
- Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
- IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days 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 of implant
- Prior heart transplant or ventricular assist device
- Mechanical tricuspid valve
- 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
- 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 informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of procedure and device-related complications 1 year Demonstrate, in the post-approval setting, that the OPTIMIZER Smart is safe to use, by assessing the rate of procedure related complications (30 days) and device related complications (1-year)
All-cause mortality 3 years Observed mortality will be compared to the predicted mortality according to the Seattle Heart Failure Model (SHFM) at 1 year and 3 years post-implant
Procedure related complications 30-days Procedure related complications through the end of 30 days following the index procedure
- Secondary Outcome Measures
Name Time Method Cardiovascular hospitalizations 2 years Change in cardiovascular hospitalization rate and HF hospitalization rate from 1-year prior to 2 years following index implantation
Trial Locations
- Locations (91)
CardioVascular Associates of Mesa (CVAM)
🇺🇸Mesa, Arizona, United States
Chan Heart Rhythm Institute (CHRI)
🇺🇸Mesa, Arizona, United States
Southwest Cardiovascular Associates
🇺🇸Mesa, Arizona, United States
Banner University Medical Center
🇺🇸Phoenix, Arizona, United States
Cardiovascular Society of Arizona
🇺🇸Phoenix, Arizona, United States
Arizona Cardiovascular Research Center
🇺🇸Phoenix, Arizona, United States
Honor Health
🇺🇸Scottsdale, Arizona, United States
Pima Heart and Vascular Research Center
🇺🇸Tucson, Arizona, United States
University of AZ - Sarver Heart Center
🇺🇸Tucson, Arizona, United States
Cardiovascular Institute of San Diego
🇺🇸Chula Vista, California, United States
NorthBay Health, Heart and Vascular
🇺🇸Fairfield, California, United States
Mid Valley Cardiology - Fresno
🇺🇸Fresno, California, United States
South Orange County Cardiology Group
🇺🇸Laguna Hills, California, United States
University of Southern California - Keck School of Medicine
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Valley Clinical Trials
🇺🇸Pasadena, California, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Aurora Denver Cardiology Associates
🇺🇸Aurora, Colorado, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Heart Rhythm Solutions
🇺🇸Davie, Florida, United States
Florida Memorial Hospital
🇺🇸Jacksonville, Florida, United States
Florida Cardiology
🇺🇸Orlando, Florida, United States
Florida Heart Rhythm Specialist
🇺🇸Plantation, Florida, United States
Piedmont Heart
🇺🇸Atlanta, Georgia, United States
Redmond Regional Medical Center
🇺🇸Rome, Georgia, United States
Advocate Illinois Masonic Medical Center
🇺🇸Chicago, Illinois, United States
Advocate Good Samaritan Hospital
🇺🇸Downers Grove, Illinois, United States
OSF Healthcare Cardiovascular Institute
🇺🇸Urbana, Illinois, United States
OSF HealthCare Cardiovascular Institute
🇺🇸Rockford, Illinois, United States
Franciscan Physician Network
🇺🇸Indianapolis, Indiana, United States
Ascension St. Vincent
🇺🇸Indianapolis, Indiana, United States
Community Healthcare System
🇺🇸Munster, Indiana, United States
Baptist Lexington
🇺🇸Lexington, Kentucky, United States
University of Kentucky - Gill Heart & Vascular Institute Clinical Research
🇺🇸Lexington, Kentucky, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Ascension Providence Park Hospital
🇺🇸Novi, Michigan, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Ascension Providence Rochester
🇺🇸Rochester, Michigan, United States
Downriver Heart and Vascular
🇺🇸Southgate, Michigan, United States
Trinity Health Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Minneapolis Heart Institute Foundation - Allina
🇺🇸Minneapolis, Minnesota, United States
St. Louis Heart and Vascular
🇺🇸Bridgeton, Missouri, United States
Logan Health
🇺🇸Kalispell, Montana, United States
Cooper Hospital
🇺🇸Haddon Heights, New Jersey, United States
Virtua Health - Our Lady of Lourdes
🇺🇸Marlton, New Jersey, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Rutgers Medical School
🇺🇸Newark, New Jersey, United States
Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Mount Sinai Morningside
🇺🇸New York, New York, United States
Mission Health
🇺🇸Asheville, North Carolina, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
NC Heart and Vascular Research
🇺🇸Raleigh, North Carolina, United States
TriHealth Hatton
🇺🇸Cincinnati, Ohio, United States
University Hospitals of Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Mount Carmel Research institute
🇺🇸Columbus, Ohio, United States
Regional Cardiac Arrythmia Inc.
🇺🇸Steubenville, Ohio, United States
ProMedica Health Systems
🇺🇸Toledo, Ohio, United States
Mercy Health - St. Vincent Medical Center
🇺🇸Toledo, Ohio, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
St. Luke's University Health Network
🇺🇸Allentown, Pennsylvania, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
UPMC Pinnacle Health
🇺🇸Harrisburg, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Penn Medicine Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Cardiology Consultants of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Penn Presybyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Heart and Vascular Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Reading Hospital
🇺🇸Reading, Pennsylvania, United States
Cardiovascular Consultants of Philadelphia
🇺🇸Yardley, Pennsylvania, United States
Texas Cardiac Arrhythmia Research
🇺🇸Austin, Texas, United States
VA North Texas Medical Center
🇺🇸Dallas, Texas, United States
Texan Procedure Center
🇺🇸El Paso, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
UT Health - Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Heart and Rhythm Institute of South Texas
🇺🇸San Antonio, Texas, United States
UT Health San Antonio
🇺🇸San Antonio, Texas, United States
CHRISTUS Trinity Clinic Research
🇺🇸Tyler, Texas, United States
Centra Health- Lynchburg General Hospital
🇺🇸Lynchburg, Virginia, United States
Bon Secours St. Mary's Hospital
🇺🇸Midlothian, Virginia, United States
HCA Chippenham Hospital
🇺🇸Richmond, Virginia, United States
Richmond VA Medical Center
🇺🇸Richmond, Virginia, United States
CAMC Clinical Trials Center
🇺🇸Charleston, West Virginia, United States
Marshall Cardiology
🇺🇸Huntington, West Virginia, United States
Aurora Research Institute
🇺🇸Milwaukee, Wisconsin, United States