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

Last updated: November 18, 2025
Sponsor: Impulse Dynamics
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Heart Failure

Hyponatremia

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:
July 31, 2028

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

    Site Not Available

  • 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

    Site Not Available

  • Honor Health

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Pima Heart & Vascular

    Tucson, Arizona 85719
    United States

    Active - Recruiting

  • Pima Heart and Vascular Research Center

    Tucson, Arizona 85712
    United States

    Site Not Available

  • University of AZ - Sarver Heart Center

    Tucson, Arizona 85724
    United States

    Active - Recruiting

  • CardioVascular Associates of Mesa (CVAM)

    Mesa 5304391, Arizona 5551752 85206
    United States

    Site Not Available

  • Chan Heart Rhythm Institute (CHRI)

    Mesa 5304391, Arizona 5551752 85206
    United States

    Site Not Available

  • Southwest Cardiovascular Associates

    Mesa 5304391, Arizona 5551752 85206
    United States

    Site Not Available

  • Arizona Cardiovascular Research Center

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Site Not Available

  • Banner University Medical Center

    Phoenix 5308655, Arizona 5551752 85006
    United States

    Site Not Available

  • Cardiovascular Society of Arizona

    Phoenix 5308655, Arizona 5551752 85006
    United States

    Site Not Available

  • Honor Health

    Scottsdale 5313457, Arizona 5551752 85258
    United States

    Site Not Available

  • Pima Heart and Vascular Research Center

    Tucson 5318313, Arizona 5551752 85712
    United States

    Site Not Available

  • University of AZ - Sarver Heart Center

    Tucson 5318313, Arizona 5551752 85724
    United States

    Site Not Available

  • Cardiovascular Institute of San Diego

    Chula Vista, California 91911
    United States

    Site Not Available

  • NorthBay Health, Heart and Vascular

    Fairfield, California 94533
    United States

    Site Not Available

  • Mid Valley Cardiology - Fresno

    Fresno, California 93720
    United States

    Site Not Available

  • South Orange County Cardiology Group

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of Southern California - Keck School of Medicine

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Valley Clinical Trials

    Northridge, California 91325
    United States

    Site Not Available

  • Valley Clinical Trials

    Pasadena, California 91105
    United States

    Site Not Available

  • Cardiovascular Institute of San Diego

    San Diego, California 92114
    United States

    Site Not Available

  • Torrance Memorial Medical Center

    Torrance, California 90505
    United States

    Site Not Available

  • Cardiovascular Institute of San Diego

    Chula Vista 5336899, California 5332921 91911
    United States

    Site Not Available

  • NorthBay Health, Heart and Vascular

    Fairfield 5347335, California 5332921 94533
    United States

    Site Not Available

  • Mid Valley Cardiology - Fresno

    Fresno 5350937, California 5332921 93720
    United States

    Site Not Available

  • South Orange County Cardiology Group

    Laguna Hills 5364306, California 5332921 92653
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Site Not Available

  • University of Southern California - Keck School of Medicine

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • Valley Clinical Trials

    Northridge 5377985, California 5332921 91325
    United States

    Site Not Available

  • Valley Clinical Trials

    Pasadena 5381396, California 5332921 91105
    United States

    Site Not Available

  • Torrance Memorial Medical Center

    Torrance 5403022, California 5332921 90505
    United States

    Site Not Available

  • Aurora Denver Cardiology Associates

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Aurora Denver Cardiology Associates

    Aurora 5412347, Colorado 5417618 80012
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar Washington Hospital Center

    Washington D.C. 4140963, District of Columbia 4138106 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

    Site Not Available

  • 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

    Site Not Available

  • Heart Rhythm Solutions

    Davie 4152820, Florida 4155751 33328
    United States

    Site Not Available

  • Florida Memorial Hospital

    Jacksonville 4160021, Florida 4155751 32216
    United States

    Site Not Available

  • Florida Cardiology

    Orlando 4167147, Florida 4155751 32792
    United States

    Site Not Available

  • Florida Heart Rhythm Specialist

    Plantation 4168782, Florida 4155751 33324
    United States

    Site Not Available

  • Piedmont Heart

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Redmond Regional Medical Center

    Rome, Georgia 30165
    United States

    Site Not Available

  • Piedmont Heart

    Atlanta 4180439, Georgia 4197000 30309
    United States

    Site Not Available

  • Redmond Regional Medical Center

    Rome 4219762, Georgia 4197000 30165
    United States

    Site Not Available

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois 60515
    United States

    Site Not Available

  • OSF Healthcare Cardiovascular Institute

    Peoria, Illinois 61614
    United States

    Site Not Available

  • OSF HealthCare Cardiovascular Institute

    Rockford, Illinois 61107
    United States

    Site Not Available

  • OSF Healthcare Cardiovascular Institute

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Advocate Illinois Masonic Medical Center

    Chicago 4887398, Illinois 4896861 60657
    United States

    Site Not Available

  • Advocate Good Samaritan Hospital

    Downers Grove 4890119, Illinois 4896861 60515
    United States

    Site Not Available

  • OSF Healthcare Cardiovascular Institute

    Peoria 4905687, Illinois 4896861 61614
    United States

    Site Not Available

  • OSF HealthCare Cardiovascular Institute

    Rockford 4907959, Illinois 4896861 61107
    United States

    Site Not Available

  • OSF Healthcare Cardiovascular Institute

    Urbana 4914570, Illinois 4896861 61801
    United States

    Site Not Available

  • Ascension St. Vincent

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Franciscan Physician Network

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • Community Healthcare System

    Munster, Indiana 46321
    United States

    Site Not Available

  • Ascension St. Vincent

    Indianapolis 4259418, Indiana 4921868 46260
    United States

    Site Not Available

  • Franciscan Physician Network

    Indianapolis 4259418, Indiana 4921868 46237
    United States

    Site Not Available

  • Community Healthcare System

    Munster 4924014, Indiana 4921868 46321
    United States

    Site Not Available

  • Baptist Lexington

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

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

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Baptist Lexington

    Lexington 4297983, Kentucky 6254925 40503
    United States

    Site Not Available

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

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02241
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02241
    United States

    Site Not Available

  • 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

    Site Not Available

  • St. Joseph Mercy Oakland

    Pontiac, Michigan 48341
    United States

    Site Not Available

  • Ascension Providence Rochester

    Rochester, Michigan 48307
    United States

    Site Not Available

  • Downriver Heart and Vascular

    Southgate, Michigan 48195
    United States

    Site Not Available

  • Trinity Health Michigan Heart

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Ascension Providence Park Hospital

    Novi 5004062, Michigan 5001836 38374
    United States

    Site Not Available

  • St. Joseph Mercy Oakland

    Pontiac 5006166, Michigan 5001836 48341
    United States

    Site Not Available

  • Downriver Heart and Vascular

    Southgate 5010646, Michigan 5001836 48195
    United States

    Site Not Available

  • Trinity Health Michigan Heart

    Ypsilanti 5015688, Michigan 5001836 48197
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation - Allina

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Minneapolis Heart Institute Foundation - Allina

    Minneapolis 5037649, Minnesota 5037779 55407
    United States

    Site Not Available

  • St. Louis Heart and Vascular

    Bridgeton, Missouri 63044
    United States

    Site Not Available

  • St. Louis Heart and Vascular

    Bridgeton 4378391, Missouri 4398678 63044
    United States

    Site Not Available

  • Logan Health

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Logan Health

    Kalispell 5660340, Montana 5667009 59901
    United States

    Site Not Available

  • Our Lady of Lourdes

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Cooper Hospital

    Haddon Heights, New Jersey 08035
    United States

    Site Not Available

  • Virtua Health - Our Lady of Lourdes

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Rutgers Medical School

    Newark, New Jersey 07719
    United States

    Site Not Available

  • Valley Hospital

    Ridgewood, New Jersey 07450
    United States

    Site Not Available

  • Cooper Hospital

    Haddon Heights 4502093, New Jersey 5101760 08035
    United States

    Site Not Available

  • Virtua Health - Our Lady of Lourdes

    Marlton 4502911, New Jersey 5101760 08053
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown 5101427, New Jersey 5101760 07960
    United States

    Site Not Available

  • Rutgers Medical School

    Newark 5101798, New Jersey 5101760 07719
    United States

    Site Not Available

  • Valley Hospital

    Ridgewood 5103269, New Jersey 5101760 07450
    United States

    Site Not Available

  • Mount Sinai Morningside

    New York, New York 10025
    United States

    Site Not Available

  • Mount Sinai Morningside

    New York 5128581, New York 5128638 10025
    United States

    Site Not Available

  • Mission Health

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Atrium Health

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • NC Heart and Vascular Research

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Mission Health

    Asheville 4453066, North Carolina 4482348 28801
    United States

    Site Not Available

  • Atrium Health

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • NC Heart and Vascular Research

    Raleigh 4487042, North Carolina 4482348 27607
    United States

    Site Not Available

  • TriHealth Hatton

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • University Hospitals of Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Mount Carmel Research institute

    Columbus, Ohio 43213
    United States

    Completed

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Regional Cardiac Arrythmia Inc.

    Steubenville, Ohio 43952
    United States

    Site Not Available

  • Mercy Health - St. Vincent Medical Center

    Toledo, Ohio 43608
    United States

    Active - Recruiting

  • ProMedica Health Systems

    Toledo, Ohio 43606
    United States

    Site Not Available

  • TriHealth Hatton

    Cincinnati 4508722, Ohio 5165418 45242
    United States

    Site Not Available

  • University Hospitals of Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Mount Carmel Research institute

    Columbus 4509177, Ohio 5165418 43213
    United States

    Site Not Available

  • The Ohio State University

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

  • Regional Cardiac Arrythmia Inc.

    Steubenville 5173048, Ohio 5165418 43952
    United States

    Site Not Available

  • Mercy Health - St. Vincent Medical Center

    Toledo 5174035, Ohio 5165418 43608
    United States

    Site Not Available

  • ProMedica Health Systems

    Toledo 5174035, Ohio 5165418 43606
    United States

    Site Not Available

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Oklahoma Heart Hospital

    Oklahoma City 4544349, Oklahoma 4544379 73120
    United States

    Site Not Available

  • Abington Memorial Hospital

    Abington, Pennsylvania 19001
    United States

    Site Not Available

  • St. Luke's University Health Network

    Allentown, Pennsylvania 18104
    United States

    Site Not Available

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania 19010
    United States

    Site Not Available

  • UPMC Pinnacle Health

    Harrisburg, Pennsylvania 17011
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Penn Medicine Lancaster General Hospital

    Lancaster, Pennsylvania 17602
    United States

    Site Not Available

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania 19141
    United States

    Active - Recruiting

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania 19067
    United States

    Site Not Available

  • 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

    Site Not Available

  • Reading Hospital

    Reading, Pennsylvania 19611
    United States

    Active - Recruiting

  • Reading Hospital | Tower Health

    Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Cardiovascular Consultants of Philadelphia

    Yardley, Pennsylvania 19067
    United States

    Site Not Available

  • St. Luke's University Health Network

    Allentown 5178127, Pennsylvania 6254927 18104
    United States

    Site Not Available

  • Bryn Mawr Hospital

    Bryn Mawr 5182063, Pennsylvania 6254927 19010
    United States

    Site Not Available

  • UPMC Pinnacle Health

    Harrisburg 5192726, Pennsylvania 6254927 17011
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey 5193342, Pennsylvania 6254927 17033
    United States

    Site Not Available

  • Penn Medicine Lancaster General Hospital

    Lancaster 5197079, Pennsylvania 6254927 17602
    United States

    Site Not Available

  • Cardiology Consultants of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19067
    United States

    Site Not Available

  • Einstein Medical Center

    Philadelphia 4560349, Pennsylvania 6254927 19141
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Penn Presybyterian Medical Center

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

  • UPMC Heart and Vascular Institute

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Reading Hospital

    Reading 5207728, Pennsylvania 6254927 19611
    United States

    Site Not Available

  • Cardiovascular Consultants of Philadelphia

    Yardley 5220281, Pennsylvania 6254927 19067
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Research

    Austin, Texas 78705
    United States

    Site Not Available

  • VA North Texas Medical Center

    Dallas, Texas 75216
    United States

    Site Not Available

  • Texan Procedure Center

    El Paso, Texas 79915
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • UT Health - Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Heart and Rhythm Institute of South Texas

    San Antonio, Texas 78229
    United States

    Completed

  • UT Health San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • CHRISTUS Trinity Clinic Research

    Tyler, Texas 75702
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Research

    Austin 4671654, Texas 4736286 78705
    United States

    Site Not Available

  • VA North Texas Medical Center

    Dallas 4684888, Texas 4736286 75216
    United States

    Site Not Available

  • Texan Procedure Center

    El Paso 5520993, Texas 4736286 79915
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • UT Health - Memorial Hermann Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Heart and Rhythm Institute of South Texas

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • UT Health San Antonio

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • CHRISTUS Trinity Clinic Research

    Tyler 4738214, Texas 4736286 75702
    United States

    Site Not Available

  • Centra Health - Lynchburg General Hospital

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • Centra Health- Lynchburg General Hospital

    Lynchburg, Virginia 24501
    United States

    Active - Recruiting

  • Bon Secours St. Mary's Hospital

    Midlothian, Virginia 23114
    United States

    Site Not Available

  • HCA Chippenham Hospital

    Richmond, Virginia 23225
    United States

    Active - Recruiting

  • Richmond VA Medical Center

    Richmond, Virginia 23249
    United States

    Site Not Available

  • Centra Health- Lynchburg General Hospital

    Lynchburg 4771075, Virginia 6254928 24501
    United States

    Site Not Available

  • Bon Secours St. Mary's Hospital

    Midlothian 4772943, Virginia 6254928 23114
    United States

    Site Not Available

  • HCA Chippenham Hospital

    Richmond 4781708, Virginia 6254928 23225
    United States

    Site Not Available

  • Richmond VA Medical Center

    Richmond 4781708, Virginia 6254928 23249
    United States

    Site Not Available

  • CAMC Clinical Trials Center

    Charleston, West Virginia 25304
    United States

    Site Not Available

  • Marshall Cardiology

    Huntington, West Virginia 25701
    United States

    Site Not Available

  • CAMC Clinical Trials Center

    Charleston 4801859, West Virginia 4826850 25304
    United States

    Site Not Available

  • Marshall Cardiology

    Huntington 4809537, West Virginia 4826850 25701
    United States

    Site Not Available

  • Aurora Research Institute

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

  • Aurora Research Institute

    Milwaukee 5263045, Wisconsin 5279468 53215
    United States

    Site Not Available

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