Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy (NCT03970343)
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
🩺 Plain-English Summary (8th-Grade Level)
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%
Who can join: Review the eligibility criteria below.
Location: CardioVascular Associates of Mesa (CVAM) — Mesa, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (90 Sites)
Showing the first 25 of 90 sites.
- CardioVascular Associates of Mesa (CVAM) — Mesa, Arizona
- Chan Heart Rhythm Institute (CHRI) — Mesa, Arizona
- Southwest Cardiovascular Associates — Mesa, Arizona
- Banner University Medical Center — Phoenix, Arizona
- Cardiovascular Society of Arizona — Phoenix, Arizona
- Arizona Cardiovascular Research Center — Phoenix, Arizona
- Honor Health — Scottsdale, Arizona
- Pima Heart and Vascular Research Center — Tucson, Arizona
- University of AZ - Sarver Heart Center — Tucson, Arizona
- Cardiovascular Institute of San Diego — Chula Vista, California
- NorthBay Health, Heart and Vascular — Fairfield, California
- Mid Valley Cardiology - Fresno — Fresno, California
- South Orange County Cardiology Group — Laguna Hills, California
- University of Southern California - Keck School of Medicine — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Valley Clinical Trials — Northridge, California
- Valley Clinical Trials — Pasadena, California
- Torrance Memorial Medical Center — Torrance, California
- Aurora Denver Cardiology Associates — Aurora, Colorado
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- Heart Rhythm Solutions — Davie, Florida
- Florida Memorial Hospital — Jacksonville, Florida
- Florida Cardiology — Orlando, Florida
- Florida Heart Rhythm Specialist — Plantation, Florida
- Piedmont Heart — Atlanta, Georgia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.