Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy

Last updated: October 9, 2024
Sponsor: Impulse Dynamics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

Heart Failure

Congestive Heart Failure

Treatment

OPTIMIZER Smart System

Clinical Study ID

NCT03970343
CA_CP_307
  • Ages > 18
  • All Genders

Study 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%

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient provides written authorization and/or consent per institution andgeographical 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 theduration of the study

  6. Patient has been treated with guideline-directed medical therapy

Exclusion

Exclusion Criteria:

  1. Primary heart failure due to uncorrected mitral valve disease, or mitral valverepair or clip within 90 days of implant

  2. IV inotropes, hemofiltration, or any form of positive inotropic support within 30days 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 ofimplant

  5. Prior heart transplant or ventricular assist device

  6. Mechanical tricuspid valve

  7. Receiving cardiac resynchronization therapy (CRT) or has a Class I indication forCRT 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 informedconsent.

Study Design

Total Participants: 620
Treatment Group(s): 1
Primary Treatment: OPTIMIZER Smart System
Phase:
Study Start date:
January 21, 2020
Estimated Completion Date:
March 01, 2026

Study 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.

Connect with a study center

  • CardioVascular Associates of Mesa (CVAM)

    Mesa, Arizona 85206
    United States

    Active - Recruiting

  • Chan Heart Rhythm Institute (CHRI)

    Mesa, Arizona 85206
    United States

    Active - Recruiting

  • Southwest Cardiovascular Associates

    Mesa, Arizona 85206
    United States

    Active - Recruiting

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Banner University Medical Center

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Cardiovascular Society of Arizona

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Honor Health

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Pima Heart & Vascular

    Tucson, Arizona 85719
    United States

    Active - Recruiting

  • Pima Heart and Vascular Research Center

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • University of AZ - Sarver Heart Center

    Tucson, Arizona 85724
    United States

    Active - Recruiting

  • Cardiovascular Institute of San Diego

    Chula Vista, California 91911
    United States

    Active - Recruiting

  • NorthBay Health, Heart and Vascular

    Fairfield, California 94533
    United States

    Active - Recruiting

  • Mid Valley Cardiology - Fresno

    Fresno, California 93720
    United States

    Active - Recruiting

  • South Orange County Cardiology Group

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • University of Southern California - Keck School of Medicine

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Valley Clinical Trials

    Northridge, California 91325
    United States

    Active - Recruiting

  • Valley Clinical Trials

    Pasadena, California 91105
    United States

    Active - Recruiting

  • Cardiovascular Institute of San Diego

    San Diego, California 92114
    United States

    Site Not Available

  • Torrance Memorial Medical Center

    Torrance, California 90505
    United States

    Active - Recruiting

  • Aurora Denver Cardiology Associates

    Aurora, Colorado 80012
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Heart Rhythm Solutions

    Davie, Florida 33328
    United States

    Site Not Available

  • Florida Memorial Hospital

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Naples Heart Rhythm Specialists

    Naples, Florida 34119
    United States

    Site Not Available

  • Florida Cardiology

    Orlando, Florida 32792
    United States

    Site Not Available

  • Florida Heart Rhythm Specialist

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Piedmont Heart

    Atlanta, Georgia 30309
    United States

    Completed

  • Redmond Regional Medical Center

    Rome, Georgia 30165
    United States

    Active - Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois 60657
    United States

    Completed

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois 60515
    United States

    Completed

  • OSF Healthcare Cardiovascular Institute

    Peoria, Illinois 61614
    United States

    Active - Recruiting

  • OSF HealthCare Cardiovascular Institute

    Rockford, Illinois 61107
    United States

    Active - Recruiting

  • OSF Healthcare Cardiovascular Institute

    Urbana, Illinois 61801
    United States

    Active - Recruiting

  • Ascension St. Vincent

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Franciscan Physician Network

    Indianapolis, Indiana 46237
    United States

    Active - Recruiting

  • Community Healthcare System

    Munster, Indiana 46321
    United States

    Active - Recruiting

  • Baptist Lexington

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • University of Kentucky - Gill Heart & Vascular Institute Clinical Research

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02241
    United States

    Active - Recruiting

  • Ascension St. John Hospital

    Detroit, Michigan 48236
    United States

    Site Not Available

  • Sparrow Clinical Research Institute

    Lansing, Michigan 48912
    United States

    Site Not Available

  • Ascension Providence Park Hospital

    Novi, Michigan 38374
    United States

    Active - Recruiting

  • St. Joseph Mercy Oakland

    Pontiac, Michigan 48341
    United States

    Completed

  • Ascension Providence Rochester

    Rochester, Michigan 48307
    United States

    Site Not Available

  • Downriver Heart and Vascular

    Southgate, Michigan 48195
    United States

    Active - Recruiting

  • Trinity Health Michigan Heart

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • Minneapolis Heart Institute Foundation - Allina

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • St. Louis Heart and Vascular

    Bridgeton, Missouri 63044
    United States

    Active - Recruiting

  • Logan Health

    Kalispell, Montana 59901
    United States

    Active - Recruiting

  • Our Lady of Lourdes

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Cooper Hospital

    Haddon Heights, New Jersey 08035
    United States

    Active - Recruiting

  • Virtua Health - Our Lady of Lourdes

    Marlton, New Jersey 08053
    United States

    Active - Recruiting

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Rutgers Medical School

    Newark, New Jersey 07719
    United States

    Active - Recruiting

  • Valley Hospital

    Ridgewood, New Jersey 07450
    United States

    Active - Recruiting

  • Mount Sinai Morningside

    New York, New York 10025
    United States

    Active - Recruiting

  • Mission Health

    Asheville, North Carolina 28801
    United States

    Active - Recruiting

  • Atrium Health

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • NC Heart and Vascular Research

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • TriHealth Hatton

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • University Hospitals of Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Mount Carmel Research institute

    Columbus, Ohio 43213
    United States

    Completed

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Regional Cardiac Arrythmia Inc.

    Steubenville, Ohio 43952
    United States

    Active - Recruiting

  • Mercy Health - St. Vincent Medical Center

    Toledo, Ohio 43608
    United States

    Active - Recruiting

  • ProMedica Health Systems

    Toledo, Ohio 43606
    United States

    Active - Recruiting

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma 73120
    United States

    Active - Recruiting

  • Abington Memorial Hospital

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • St. Luke's University Health Network

    Allentown, Pennsylvania 18104
    United States

    Active - Recruiting

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania 19010
    United States

    Active - Recruiting

  • UPMC Pinnacle Health

    Harrisburg, Pennsylvania 17011
    United States

    Active - Recruiting

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Penn Medicine Lancaster General Hospital

    Lancaster, Pennsylvania 17602
    United States

    Active - Recruiting

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania 19141
    United States

    Active - Recruiting

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania 19067
    United States

    Active - Recruiting

  • Einstein Medical Center

    Philadelphia, Pennsylvania 19141
    United States

    Active - Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Completed

  • Penn Presybyterian Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • UPMC Heart and Vascular Institute

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Reading Hospital

    Reading, Pennsylvania 19611
    United States

    Active - Recruiting

  • Reading Hospital | Tower Health

    Reading, Pennsylvania 19611
    United States

    Active - Recruiting

  • Cardiovascular Consultants of Philadelphia

    Yardley, Pennsylvania 19067
    United States

    Active - Recruiting

  • Texas Cardiac Arrhythmia Research

    Austin, Texas 78705
    United States

    Active - Recruiting

  • VA North Texas Medical Center

    Dallas, Texas 75216
    United States

    Active - Recruiting

  • Texan Procedure Center

    El Paso, Texas 79915
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • UT Health - Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Heart and Rhythm Institute of South Texas

    San Antonio, Texas 78229
    United States

    Completed

  • UT Health San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • CHRISTUS Trinity Clinic Research

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Centra Health - Lynchburg General Hospital

    Lynchburg, Virginia 24501
    United States

    Active - Recruiting

  • Centra Health- Lynchburg General Hospital

    Lynchburg, Virginia 24501
    United States

    Active - Recruiting

  • Bon Secours St. Mary's Hospital

    Midlothian, Virginia 23114
    United States

    Active - Recruiting

  • HCA Chippenham Hospital

    Richmond, Virginia 23225
    United States

    Active - Recruiting

  • Richmond VA Medical Center

    Richmond, Virginia 23249
    United States

    Active - Recruiting

  • CAMC Clinical Trials Center

    Charleston, West Virginia 25304
    United States

    Completed

  • Marshall Cardiology

    Huntington, West Virginia 25701
    United States

    Active - Recruiting

  • Aurora Research Institute

    Milwaukee, Wisconsin 53215
    United States

    Active - Recruiting

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