Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy (NCT03970343) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
United States620 participantsStarted 2020-01-21
Plain-language 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%
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. 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
What they're measuring
1
Incidence of procedure and device-related complications