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

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Overview

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%

Clinical Trial Information

Protocol

IRB #26795

Phase

4

Condition(s)

Heart Failure

Investigator

Isaac Whitman, MD

Contact

For more information about this trial or to inquire about eligibility, call the research office at 215-707-5340.

Visit clinicaltrials.gov for full description

Full 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