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

Description

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%

Conditions

Heart Failure

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Study Overview

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Study Details

Study 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%

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

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

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Mesa

CardioVascular Associates of Mesa (CVAM), Mesa, Arizona, United States, 85206

Mesa

Chan Heart Rhythm Institute (CHRI), Mesa, Arizona, United States, 85206

Mesa

Southwest Cardiovascular Associates, Mesa, Arizona, United States, 85206

Phoenix

Banner University Medical Center, Phoenix, Arizona, United States, 85006

Phoenix

Cardiovascular Society of Arizona, Phoenix, Arizona, United States, 85006

Phoenix

Arizona Cardiovascular Research Center, Phoenix, Arizona, United States, 85016

Scottsdale

Honor Health, Scottsdale, Arizona, United States, 85258

Tucson

Pima Heart and Vascular Research Center, Tucson, Arizona, United States, 85712

Tucson

University of AZ - Sarver Heart Center, Tucson, Arizona, United States, 85724

Chula Vista

Cardiovascular Institute of San Diego, Chula Vista, California, United States, 91911

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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, per site assessment)
  • 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 medical therapy
  • 1. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
  • 2. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
  • 3. Myocardial infarction within 90 days prior to implant
  • 4. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
  • 5. Prior heart transplant or ventricular assist device
  • 6. Mechanical tricuspid valve
  • 7. 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
  • 8. Participating in a cardiac investigational study at the same time
  • 9. 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Impulse Dynamics,

Rami Kahwash, MD, STUDY_DIRECTOR, The Ohio State University Wexner Medical Center

Raul Weiss, MD, STUDY_DIRECTOR, Mt. Sinai Miami

Study Record Dates

2026-03-01