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ACTIVE NOT RECRUITING

NCT03970343

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

Sponsor: Impulse Dynamics

View on ClinicalTrials.gov

Summary

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%

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

620

Start Date

2020-01-21

Completion Date

2028-07

Last Updated

2025-11-20

Healthy Volunteers

Conditions

Heart Failure

Interventions

DEVICE

OPTIMIZER Smart System

Eligible subjects will receive the OPTIMIZER Smart, which is comprised of three major components: 1. Optimizer Smart or Optimizer Smart Mini 2. Vesta Charger or Guardio Charger 3. Two commercially available intravascular leads

Locations (90)

CardioVascular Associates of Mesa (CVAM)

Mesa, Arizona, United States

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

Redmond Regional Medical Center

Rome, Georgia, United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

OSF Healthcare Cardiovascular Institute

Peoria, Illinois, United States

OSF HealthCare Cardiovascular Institute

Rockford, Illinois, United States

OSF Healthcare Cardiovascular Institute

Urbana, Illinois, United States

Franciscan Physician Network

Indianapolis, Indiana, United States

Ascension St. Vincent

Indianapolis, Indiana, United States

Community Healthcare System

Munster, Indiana, United States

Baptist Lexington

Lexington, Kentucky, United States

University of Kentucky - Gill Heart & Vascular Institute Clinical Research

Lexington, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Ascension Providence Park Hospital

Novi, Michigan, United States

St. Joseph Mercy Oakland

Pontiac, Michigan, United States

Downriver Heart and Vascular

Southgate, Michigan, United States

Trinity Health Michigan Heart

Ypsilanti, Michigan, United States

Minneapolis Heart Institute Foundation - Allina

Minneapolis, Minnesota, United States

St. Louis Heart and Vascular

Bridgeton, Missouri, United States

Logan Health

Kalispell, Montana, United States

Cooper Hospital

Haddon Heights, New Jersey, United States

Virtua Health - Our Lady of Lourdes

Marlton, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

Rutgers Medical School

Newark, New Jersey, United States

Valley Hospital

Ridgewood, New Jersey, United States

Mount Sinai Morningside

New York, New York, United States

Mission Health

Asheville, North Carolina, United States

Atrium Health

Charlotte, North Carolina, United States

NC Heart and Vascular Research

Raleigh, North Carolina, United States

TriHealth Hatton

Cincinnati, Ohio, United States

University Hospitals of Cleveland Medical Center

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Mount Carmel Research institute

Columbus, Ohio, United States

Regional Cardiac Arrythmia Inc.

Steubenville, Ohio, United States

ProMedica Health Systems

Toledo, Ohio, United States

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

St. Luke's University Health Network

Allentown, Pennsylvania, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

UPMC Pinnacle Health

Harrisburg, Pennsylvania, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Penn Medicine Lancaster General Hospital

Lancaster, Pennsylvania, United States

Cardiology Consultants of Philadelphia