OPTIMIZER Smart Post Approval Study

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

Sex at Birth: Any
Age: Adult (18 - 64), Older Adult (65+)
Accepting Healthy People: No
Type: Interventional / Therapeutic
Trial Phase: Phase IV
Conditions Being Studied: Heart Failure

Study Purpose

The purpose of this post approval study (PAS) is to evaluate the safety of long-term use of the OPTIMIZER Smart and called cardiac contractility modulation (CCM) therapy. The PAS will also evaluate the effects of CCM therapy on quality of life and heart failure symptoms, as well as the hearts ability to pump effectively (echo) and some potential blood related chemical changes.

Who Can Participate

Age: 18 and older

Principal Investigator
Ivan Cakulev MD

Department/Division
Heart and Vascular (Electrophysiology)

Locations

UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106

Get Directions

UH IRB: SITE00001278
StudyID: 2020-0371
ClinicalTrials.gov: NCT03970343

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