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

November 18, 2025 updated by: Impulse Dynamics

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

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%

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

620

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Southwest Cardiovascular Associates
      • Mesa, Arizona, United States, 85206
        • CardioVascular Associates of Mesa (CVAM)
      • Mesa, Arizona, United States, 85206
        • Chan Heart Rhythm Institute (CHRI)
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center
      • Phoenix, Arizona, United States, 85016
        • Arizona Cardiovascular Research Center
      • Phoenix, Arizona, United States, 85006
        • Cardiovascular Society of Arizona
      • Scottsdale, Arizona, United States, 85258
        • Honor Health
      • Tucson, Arizona, United States, 85712
        • Pima Heart and Vascular Research Center
      • Tucson, Arizona, United States, 85724
        • University of AZ - Sarver Heart Center
    • California
      • Chula Vista, California, United States, 91911
        • Cardiovascular Institute of San Diego
      • Fairfield, California, United States, 94533
        • NorthBay Health, Heart and Vascular
      • Fresno, California, United States, 93720
        • Mid Valley Cardiology - Fresno
      • Laguna Hills, California, United States, 92653
        • South Orange County Cardiology Group
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • University of Southern California - Keck School of Medicine
      • Northridge, California, United States, 91325
        • Valley Clinical Trials
      • Pasadena, California, United States, 91105
        • Valley Clinical Trials
      • Torrance, California, United States, 90505
        • Torrance Memorial Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Aurora Denver Cardiology Associates
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Davie, Florida, United States, 33328
        • Heart Rhythm Solutions
      • Jacksonville, Florida, United States, 32216
        • Florida Memorial Hospital
      • Orlando, Florida, United States, 32792
        • Florida Cardiology
      • Plantation, Florida, United States, 33324
        • Florida Heart Rhythm Specialist
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart
      • Rome, Georgia, United States, 30165
        • Redmond Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Advocate Illinois Masonic Medical Center
      • Downers Grove, Illinois, United States, 60515
        • Advocate Good Samaritan Hospital
      • Peoria, Illinois, United States, 61614
        • OSF HealthCare Cardiovascular Institute
      • Rockford, Illinois, United States, 61107
        • OSF HealthCare Cardiovascular Institute
      • Urbana, Illinois, United States, 61801
        • OSF HealthCare Cardiovascular Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Ascension St. Vincent
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Physician Network
      • Munster, Indiana, United States, 46321
        • Community Healthcare System
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Lexington
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky - Gill Heart & Vascular Institute Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02241
        • Massachusetts General Hospital
    • Michigan
      • Novi, Michigan, United States, 38374
        • Ascension Providence Park Hospital
      • Pontiac, Michigan, United States, 48341
        • St. Joseph Mercy Oakland
      • Southgate, Michigan, United States, 48195
        • Downriver Heart and Vascular
      • Ypsilanti, Michigan, United States, 48197
        • Trinity Health Michigan Heart
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation - Allina
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • St. Louis Heart and Vascular
    • Montana
      • Kalispell, Montana, United States, 59901
        • Logan Health
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
        • Cooper Hospital
      • Marlton, New Jersey, United States, 08053
        • Virtua Health - Our Lady of Lourdes
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • Newark, New Jersey, United States, 07719
        • Rutgers Medical School
      • Ridgewood, New Jersey, United States, 07450
        • Valley Hospital
    • New York
      • New York, New York, United States, 10025
        • Mount Sinai Morningside
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Health
      • Charlotte, North Carolina, United States, 28204
        • Atrium Health
      • Raleigh, North Carolina, United States, 27607
        • NC Heart and Vascular Research
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • TriHealth Hatton
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Of Cleveland Medical Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Columbus, Ohio, United States, 43213
        • Mount Carmel Research Institute
      • Steubenville, Ohio, United States, 43952
        • Regional Cardiac Arrythmia Inc.
      • Toledo, Ohio, United States, 43608
        • Mercy Health - St. Vincent Medical Center
      • Toledo, Ohio, United States, 43606
        • ProMedica Health Systems
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • St. Luke's University Health Network
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
      • Harrisburg, Pennsylvania, United States, 17011
        • UPMC Pinnacle Health
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center
      • Lancaster, Pennsylvania, United States, 17602
        • Penn Medicine Lancaster General Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Medical Center
      • Philadelphia, Pennsylvania, United States, 19067
        • Cardiology Consultants of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presybyterian Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Heart and Vascular Institute
      • Reading, Pennsylvania, United States, 19611
        • Reading Hospital
      • Yardley, Pennsylvania, United States, 19067
        • Cardiovascular Consultants of Philadelphia
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research
      • Dallas, Texas, United States, 75216
        • VA North Texas Medical Center
      • El Paso, Texas, United States, 79915
        • Texan Procedure Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • UT Health - Memorial Hermann Hospital
      • San Antonio, Texas, United States, 78229
        • UT Health San Antonio
      • San Antonio, Texas, United States, 78229
        • Heart and Rhythm Institute of South Texas
      • Tyler, Texas, United States, 75702
        • CHRISTUS Trinity Clinic Research
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Centra Health- Lynchburg General Hospital
      • Midlothian, Virginia, United States, 23114
        • Bon Secours St. Mary's Hospital
      • Richmond, Virginia, United States, 23249
        • Richmond VA Medical Center
      • Richmond, Virginia, United States, 23225
        • HCA Chippenham Hospital
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Clinical Trials Center
      • Huntington, West Virginia, United States, 25701
        • Marshall Cardiology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants will represent a patient population with stable, systolic left ventricular dysfunction and moderate symptomatic heart failure despite guideline-directed medical therapy.

Description

Inclusion Criteria:

  1. Patient provides written authorization and/or consent per institution and geographical 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 the duration of the study
  6. Patient has been treated with guideline-directed medical therapy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of procedure and device-related complications
Time Frame: 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)
1 year
All-cause mortality
Time Frame: 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
3 years
Procedure related complications
Time Frame: 30-days
Procedure related complications through the end of 30 days following the index procedure
30-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular hospitalizations
Time Frame: 2 years
Change in cardiovascular hospitalization rate and HF hospitalization rate from 1-year prior to 2 years following index implantation
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Impulse Dynamics

Investigators

  • Study Director: Raul Weiss, MD, Mt. Sinai Miami
  • Study Director: Rami Kahwash, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2020

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

May 30, 2019

First Posted (Actual)

May 31, 2019

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA_CP_307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe