Heart FailurePASNCT03970343
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
An observational study of Heart Failure, run by Impulse Dynamics at 90 sites in United States.
Trial 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% Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- OPTIMIZER Smart System
- Type of treatment
- Medical device
- How many people
- 620 participants
- Where
- 90 sitesUnited States
- Study dates
- 21 Jan 2020to Jul 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will represent a patient population with stable, systolic left ventricular dysfunction and moderate symptomatic heart failure despite guideline-directed medical therapy.
Who may be able to join
- Patient provides written authorization and/or consent per institution and geographical requirements
- Male or non-pregnant female, aged 18 or older
- Left ventricular ejection fraction of 25-45% (inclusive, per site assessment)
- NYHA Class III heart failure symptoms
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Patient has been treated with guideline-directed medical therapy
Who cannot join
- Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
- IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
- Myocardial infarction within 90 days prior to implant
- Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
- Prior heart transplant or ventricular assist device
- Mechanical tricuspid valve
Show all 9Show fewer
- 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
- Participating in a cardiac investigational study at the same time
- 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.
Trial locations and contacts
90 sites in 1 country.
90 sites in 1 country
United States90 sites
St. Luke's University Health Network
Allentown, Pennsylvania, 18104
Mission Health
Asheville, North Carolina, 28801
Piedmont Heart
Atlanta, Georgia, 30309
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
Massachusetts General Hospital
Boston, Massachusetts, 02241
St. Louis Heart and Vascular
Bridgeton, Missouri, 63044
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
CAMC Clinical Trials Center
Charleston, West Virginia, 25304
Atrium Health
Charlotte, North Carolina, 28204
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Cardiovascular Institute of San Diego
Chula Vista, California, 91911
TriHealth Hatton
Cincinnati, Ohio, 45242
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, 44106
The Ohio State University
Columbus, Ohio, 43210
Mount Carmel Research institute
Columbus, Ohio, 43213
VA North Texas Medical Center
Dallas, Texas, 75216
Heart Rhythm Solutions
Davie, Florida, 33328
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Texan Procedure Center
El Paso, Texas, 79915
NorthBay Health, Heart and Vascular
Fairfield, California, 94533
Mid Valley Cardiology - Fresno
Fresno, California, 93720
Cooper Hospital
Haddon Heights, New Jersey, 08035
UPMC Pinnacle Health
Harrisburg, Pennsylvania, 17011
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Baylor College of Medicine
Houston, Texas, 77030
UT Health - Memorial Hermann Hospital
Houston, Texas, 77030
Marshall Cardiology
Huntington, West Virginia, 25701
Franciscan Physician Network
Indianapolis, Indiana, 46237
Ascension St. Vincent
Indianapolis, Indiana, 46260
Florida Memorial Hospital
Jacksonville, Florida, 32216
Logan Health
Kalispell, Montana, 59901
South Orange County Cardiology Group
Laguna Hills, California, 92653
Penn Medicine Lancaster General Hospital
Lancaster, Pennsylvania, 17602
Baptist Lexington
Lexington, Kentucky, 40503
University of Kentucky - Gill Heart & Vascular Institute Clinical Research
Lexington, Kentucky, 40536
University of Southern California - Keck School of Medicine
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Centra Health- Lynchburg General Hospital
Lynchburg, Virginia, 24501
Virtua Health - Our Lady of Lourdes
Marlton, New Jersey, 08053
CardioVascular Associates of Mesa (CVAM)
Mesa, Arizona, 85206
Chan Heart Rhythm Institute (CHRI)
Mesa, Arizona, 85206
Southwest Cardiovascular Associates
Mesa, Arizona, 85206
Bon Secours St. Mary's Hospital
Midlothian, Virginia, 23114
Aurora Research Institute
Milwaukee, Wisconsin, 53215
Minneapolis Heart Institute Foundation - Allina
Minneapolis, Minnesota, 55407
Morristown Medical Center
Morristown, New Jersey, 07960
Community Healthcare System
Munster, Indiana, 46321
Mount Sinai Morningside
New York, New York, 10025
Rutgers Medical School
Newark, New Jersey, 07719
Valley Clinical Trials
Northridge, California, 91325
Ascension Providence Park Hospital
Novi, Michigan, 38374
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Florida Cardiology
Orlando, Florida, 32792
Valley Clinical Trials
Pasadena, California, 91105
OSF Healthcare Cardiovascular Institute
Peoria, Illinois, 61614
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, 19067
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presybyterian Medical Center
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Banner University Medical Center
Phoenix, Arizona, 85006
Cardiovascular Society of Arizona
Phoenix, Arizona, 85006
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania, 15213
Florida Heart Rhythm Specialist
Plantation, Florida, 33324
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
Reading Hospital
Reading, Pennsylvania, 19611
HCA Chippenham Hospital
Richmond, Virginia, 23225
Richmond VA Medical Center
Richmond, Virginia, 23249
Valley Hospital
Ridgewood, New Jersey, 07450
OSF HealthCare Cardiovascular Institute
Rockford, Illinois, 61107
Redmond Regional Medical Center
Rome, Georgia, 30165
Heart and Rhythm Institute of South Texas
San Antonio, Texas, 78229
UT Health San Antonio
San Antonio, Texas, 78229
Honor Health
Scottsdale, Arizona, 85258
Downriver Heart and Vascular
Southgate, Michigan, 48195
Regional Cardiac Arrythmia Inc.
Steubenville, Ohio, 43952
ProMedica Health Systems
Toledo, Ohio, 43606
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608
Torrance Memorial Medical Center
Torrance, California, 90505
Pima Heart and Vascular Research Center
Tucson, Arizona, 85712
University of AZ - Sarver Heart Center
Tucson, Arizona, 85724
CHRISTUS Trinity Clinic Research
Tyler, Texas, 75702
OSF Healthcare Cardiovascular Institute
Urbana, Illinois, 61801
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Cardiovascular Consultants of Philadelphia
Yardley, Pennsylvania, 19067
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48197
About this study
Official title: 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%
Read the 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.
- Conditions
- Heart Failure
- Being tested
- OPTIMIZER Smart System
- Keywords
- OPTIMIZER, Heart Failure, CCM, Post-Approval Study, NYHA class III, FIX-HF-5C, Chronic heart failure, Ejection fraction between 25 and 45, cardiac contractility modulation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMIZER Smart SystemDevice
Eligible subjects will receive the OPTIMIZER Smart, which is comprised of three major components:
- Optimizer Smart or Optimizer Smart Mini
- Vesta Charger or Guardio Charger
- Two commercially available intravascular leads
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of procedure and device-related complications
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)
Measured: 1 year
All-cause mortality
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
Measured: 3 years
Procedure related complications
Procedure related complications through the end of 30 days following the index procedure
Measured: 30-days
Secondary outcomes (1)
Cardiovascular hospitalizations
Change in cardiovascular hospitalization rate and HF hospitalization rate from 1-year prior to 2 years following index implantation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start21 Jan 2020
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 620 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Impulse Dynamics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rami Kahwash, MD, Study director, Ohio State UniversityRaul Weiss, MD, Study director, Mt. Sinai Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970343
- Sponsor's protocol ID
- CA_CP_307
- Acronym
- PAS
- Status last verified
- Nov 2025
- First submitted
- 23 May 2019
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03970343
- Acronym / sponsor ID
- PAS / CA_CP_307
- Conditions
- Heart Failure
- Keywords
- OPTIMIZER, Heart Failure, CCM, Post-Approval Study, NYHA class III, FIX-HF-5C, Chronic heart failure, Ejection fraction between 25 and 45
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Impulse DynamicsIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 31 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will represent a patient population with stable, systolic left ventricular dysfunction and moderate symptomatic heart failure despite guideline-directed medical therapy.
Key inclusion criteria (6 listed)
- Patient provides written authorization and/or consent per institution and geographical requirements
- Male or non-pregnant female, aged 18 or older
- Left ventricular ejection fraction of 25-45% (inclusive, per site assessment)
- NYHA Class III heart failure symptoms
- Stated willingness to comply with all study procedures and availability for the duration of the study
Key exclusion criteria (9 listed)
- Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
- IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
- Myocardial infarction within 90 days prior to implant
- Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
- Prior heart transplant or ventricular assist device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTIMIZER Smart SystemEligible 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 | Device | – |
Primary outcome
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)
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
Procedure related complications
Time frame: 30-days
Procedure related complications through the end of 30 days following the index procedure
1 secondary outcome
Cardiovascular hospitalizations
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rami Kahwash, MD study director
Ohio State University
Raul Weiss, MD study director
Mt. Sinai Miami
90 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Impulse Dynamics at 90 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of procedure and device-related complications (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.