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

ID#: NCT03970343

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: January 21, 2020

End Date: December 01, 2023

Contact Information:
Angela Stagg

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%


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