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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Impulse Dynamics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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