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

Active, not recruiting · NCT03970343

Conditions: Heart Failure

At a glance

Research payments reported, 2025
$592,961
U.S. investigators named
74
Sites paid
72
Planned or actual enrollment
620

About the trial

Sponsor
Impulse Dynamics
Tested
OPTIMIZER Smart System (device)
Dates
Started 2020-01-21; completion 2028-07
Results posted
Not yet

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%

From ClinicalTrials.gov, last updated 2025-11-20. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Impulse Dynamics (USA) Inc. reported $592,961 in research payments for this study in 2025 (384 payments).

Products named: Optimizer

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.