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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03970343
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Impulse Dynamics

Brief 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%

Condition or disease Intervention/treatment
Heart Failure Device: OPTIMIZER Smart

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 620 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Device: OPTIMIZER Smart

    Eligible subjects will receive the OPTIMIZER Smart, which is comprised of three major components:

    1. Programmable Optimizer Smart Implantable Pulse Generator (IPG)
    2. OMNI Smart Programmer
    3. Optimizer Smart Charger

    Two commercially available intravascular leads complete the system.



Primary Outcome Measures :
  1. 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)

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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)
  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 heart failure therapies with stable doses for at least 30 days prior to implant

Exclusion Criteria:

  1. Infiltrative or inflammatory cardiomyopathy (e.g. amyloid, hemochromatosis, myocarditis, hypertrophic cardiomyopathy, Fabry disease, cardiac tumor)
  2. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days prior to implant
  3. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant, including continuous IV inotrope therapy
  4. Myocardial infarction within 90 days prior to implant
  5. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days prior to implant
  6. Persistent (lasting more than 7 days) or permanent lasting more than 1 year) atrial fibrillation or atrial flutter or cardioverted within 30 days prior to implant
  7. Prior heart transplant or ventricular assist device
  8. Mechanical tricuspid valve
  9. PR interval greater than 375ms
  10. 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
  11. Currently on dialysis
  12. Currently undergoing treatment for cancer
  13. Participating in another cardiac investigational study at the same time
  14. 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.
  15. Other criteria that precludes Optimizer implantation and/or CCM therapy, as determined by Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970343


Contacts
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Contact: Angela Stagg 845-359-2389 ext 206 angelas@impulse-dynamics.com

Locations
Show Show 27 study locations
Sponsors and Collaborators
Impulse Dynamics
Investigators
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Study Director: Rami Kahwash, MD The Ohio State University Wexner Medical Center
Study Director: Raul Weiss, MD The Ohio State University Wexner Medical Center
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Responsible Party: Impulse Dynamics
ClinicalTrials.gov Identifier: NCT03970343    
Other Study ID Numbers: CA_CP_307
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Impulse Dynamics:
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
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases