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

Running, not enrolling

Conditions studied: Heart Failure

In brief

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%

Key facts

Study ID

NCT03970343

Run by

Impulse Dynamics

People needed

620

Starts

2020-01-21

Expected to finish

2028-07-01

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Participating in a cardiac investigational study at the same time
• 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.

Where it is running

• Chan Heart Rhythm Institute (CHRI) — Mesa, Arizona, United States
• Southwest Cardiovascular Associates — Mesa, Arizona, United States
• Banner University Medical Center — Phoenix, Arizona, United States
• Cardiovascular Society of Arizona — Phoenix, Arizona, United States
• Arizona Cardiovascular Research Center — Phoenix, Arizona, United States
• Honor Health — Scottsdale, Arizona, United States
• Pima Heart and Vascular Research Center — Tucson, Arizona, United States
• University of AZ - Sarver Heart Center — Tucson, Arizona, United States
• Cardiovascular Institute of San Diego — Chula Vista, California, United States
• NorthBay Health, Heart and Vascular — Fairfield, California, United States
• Mid Valley Cardiology - Fresno — Fresno, California, United States
• South Orange County Cardiology Group — Laguna Hills, California, United States
• University of Southern California - Keck School of Medicine — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Valley Clinical Trials — Northridge, California, United States
• Valley Clinical Trials — Pasadena, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Aurora Denver Cardiology Associates — Aurora, Colorado, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Heart Rhythm Solutions — Davie, Florida, United States
• Florida Memorial Hospital — Jacksonville, Florida, United States
• Florida Cardiology — Orlando, Florida, United States
• Florida Heart Rhythm Specialist — Plantation, Florida, United States
• Piedmont Heart — Atlanta, Georgia, United States
• CardioVascular Associates of Mesa (CVAM) — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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