Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
NCT ID: NCT03970343
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
620 participants
OBSERVATIONAL
2020-01-21
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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OPTIMIZER Smart System
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
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Impulse Dynamics
INDUSTRY
Responsible Party
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Principal Investigators
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Rami Kahwash, MD
Role: STUDY_DIRECTOR
Ohio State University
Raul Weiss, MD
Role: STUDY_DIRECTOR
Mt. Sinai Miami
Locations
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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
Northridge, 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 D.C., 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
Peoria, Illinois, United States
OSF HealthCare Cardiovascular Institute
Rockford, Illinois, United States
OSF Healthcare Cardiovascular Institute
Urbana, 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
Ascension Providence Park Hospital
Novi, Michigan, United States
St. Joseph Mercy Oakland
Pontiac, 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
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
Countries
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Other Identifiers
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CA_CP_307
Identifier Type: -
Identifier Source: org_study_id
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