Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
PAS
A Prospective, Multi-center, Non-randomized, Single Arm Open Label Study of 620 Subjects Receiving the OPTIMIZER Smart With CCM Therapy as Standard of Care
1 other identifier
observational
620
1 country
90
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%
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 31, 2019
CompletedStudy Start
First participant enrolled
January 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
November 20, 2025
November 1, 2025
8.4 years
May 23, 2019
November 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of procedure and device-related complications
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)
1 year
All-cause mortality
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
3 years
Procedure related complications
Procedure related complications through the end of 30 days following the index procedure
30-days
Secondary Outcomes (1)
Cardiovascular hospitalizations
2 years
Interventions
Eligible subjects will receive the OPTIMIZER Smart, which is comprised of three major components: 1. Optimizer Smart or Optimizer Smart Mini 2. Vesta Charger or Guardio Charger 3. Two commercially available intravascular leads
Eligibility Criteria
Participants will represent a patient population with stable, systolic left ventricular dysfunction and moderate symptomatic heart failure despite guideline-directed medical therapy.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Impulse Dynamicslead
Study Sites (90)
CardioVascular Associates of Mesa (CVAM)
Mesa, Arizona, 85206, United States
Chan Heart Rhythm Institute (CHRI)
Mesa, Arizona, 85206, United States
Southwest Cardiovascular Associates
Mesa, Arizona, 85206, United States
Banner University Medical Center
Phoenix, Arizona, 85006, United States
Cardiovascular Society of Arizona
Phoenix, Arizona, 85006, United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016, United States
Honor Health
Scottsdale, Arizona, 85258, United States
Pima Heart and Vascular Research Center
Tucson, Arizona, 85712, United States
University of AZ - Sarver Heart Center
Tucson, Arizona, 85724, United States
Cardiovascular Institute of San Diego
Chula Vista, California, 91911, United States
NorthBay Health, Heart and Vascular
Fairfield, California, 94533, United States
Mid Valley Cardiology - Fresno
Fresno, California, 93720, United States
South Orange County Cardiology Group
Laguna Hills, California, 92653, United States
University of Southern California - Keck School of Medicine
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Valley Clinical Trials
Northridge, California, 91325, United States
Valley Clinical Trials
Pasadena, California, 91105, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Heart Rhythm Solutions
Davie, Florida, 33328, United States
Florida Memorial Hospital
Jacksonville, Florida, 32216, United States
Florida Cardiology
Orlando, Florida, 32792, United States
Florida Heart Rhythm Specialist
Plantation, Florida, 33324, United States
Piedmont Heart
Atlanta, Georgia, 30309, United States
Redmond Regional Medical Center
Rome, Georgia, 30165, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
OSF Healthcare Cardiovascular Institute
Peoria, Illinois, 61614, United States
OSF HealthCare Cardiovascular Institute
Rockford, Illinois, 61107, United States
OSF Healthcare Cardiovascular Institute
Urbana, Illinois, 61801, United States
Franciscan Physician Network
Indianapolis, Indiana, 46237, United States
Ascension St. Vincent
Indianapolis, Indiana, 46260, United States
Community Healthcare System
Munster, Indiana, 46321, United States
Baptist Lexington
Lexington, Kentucky, 40503, United States
University of Kentucky - Gill Heart & Vascular Institute Clinical Research
Lexington, Kentucky, 40536, United States
Massachusetts General Hospital
Boston, Massachusetts, 02241, United States
Ascension Providence Park Hospital
Novi, Michigan, 38374, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Downriver Heart and Vascular
Southgate, Michigan, 48195, United States
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48197, United States
Minneapolis Heart Institute Foundation - Allina
Minneapolis, Minnesota, 55407, United States
St. Louis Heart and Vascular
Bridgeton, Missouri, 63044, United States
Logan Health
Kalispell, Montana, 59901, United States
Cooper Hospital
Haddon Heights, New Jersey, 08035, United States
Virtua Health - Our Lady of Lourdes
Marlton, New Jersey, 08053, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Rutgers Medical School
Newark, New Jersey, 07719, United States
Valley Hospital
Ridgewood, New Jersey, 07450, United States
Mount Sinai Morningside
New York, New York, 10025, United States
Mission Health
Asheville, North Carolina, 28801, United States
Atrium Health
Charlotte, North Carolina, 28204, United States
NC Heart and Vascular Research
Raleigh, North Carolina, 27607, United States
TriHealth Hatton
Cincinnati, Ohio, 45242, United States
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Mount Carmel Research institute
Columbus, Ohio, 43213, United States
Regional Cardiac Arrythmia Inc.
Steubenville, Ohio, 43952, United States
ProMedica Health Systems
Toledo, Ohio, 43606, United States
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120, United States
St. Luke's University Health Network
Allentown, Pennsylvania, 18104, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
UPMC Pinnacle Health
Harrisburg, Pennsylvania, 17011, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Penn Medicine Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, 19067, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Penn Presybyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania, 15213, United States
Reading Hospital
Reading, Pennsylvania, 19611, United States
Cardiovascular Consultants of Philadelphia
Yardley, Pennsylvania, 19067, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705, United States
VA North Texas Medical Center
Dallas, Texas, 75216, United States
Texan Procedure Center
El Paso, Texas, 79915, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
UT Health - Memorial Hermann Hospital
Houston, Texas, 77030, United States
Heart and Rhythm Institute of South Texas
San Antonio, Texas, 78229, United States
UT Health San Antonio
San Antonio, Texas, 78229, United States
CHRISTUS Trinity Clinic Research
Tyler, Texas, 75702, United States
Centra Health- Lynchburg General Hospital
Lynchburg, Virginia, 24501, United States
Bon Secours St. Mary's Hospital
Midlothian, Virginia, 23114, United States
HCA Chippenham Hospital
Richmond, Virginia, 23225, United States
Richmond VA Medical Center
Richmond, Virginia, 23249, United States
CAMC Clinical Trials Center
Charleston, West Virginia, 25304, United States
Marshall Cardiology
Huntington, West Virginia, 25701, United States
Aurora Research Institute
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rami Kahwash, MD
Ohio State University
- STUDY DIRECTOR
Raul Weiss, MD
Mt. Sinai Miami
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2019
First Posted
May 31, 2019
Study Start
January 21, 2020
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
November 20, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share