ACTIVE_NOT_RECRUITING

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

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Conditions

Heart FailureOPTIMIZERCCMPost-Approval StudyNYHA class IIIFIX-HF-5CChronic heart failureEjection fraction between 25 and 45cardiac contractility modulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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%

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

Quick Facts

Study Start:2020-01-21
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03970343

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient provides written authorization and/or consent per institution and geographical requirements
  2. 2. Male or non-pregnant female, aged 18 or older
  3. 3. Left ventricular ejection fraction of 25-45% (inclusive, per site assessment)
  4. 4. NYHA Class III heart failure symptoms
  5. 5. Stated willingness to comply with all study procedures and availability for the duration of the study
  6. 6. Patient has been treated with guideline-directed medical therapy
  1. 1. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
  2. 2. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
  3. 3. Myocardial infarction within 90 days prior to implant
  4. 4. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
  5. 5. Prior heart transplant or ventricular assist device
  6. 6. Mechanical tricuspid valve
  7. 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. 8. Participating in a cardiac investigational study at the same time
  9. 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.

Contacts and Locations

Principal Investigator

Rami Kahwash, MD
STUDY_DIRECTOR
Ohio State University
Raul Weiss, MD
STUDY_DIRECTOR
Mt. Sinai Miami

Study Locations (Sites)

CardioVascular Associates of Mesa (CVAM)
Mesa, Arizona, 85206
United States
Chan Heart Rhythm Institute (CHRI)
Mesa, Arizona, 85206
United States
Southwest Cardiovascular Associates
Mesa, Arizona, 85206
United States
Banner University Medical Center
Phoenix, Arizona, 85006
United States
Cardiovascular Society of Arizona
Phoenix, Arizona, 85006
United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016
United States
Honor Health
Scottsdale, Arizona, 85258
United States
Pima Heart and Vascular Research Center
Tucson, Arizona, 85712
United States
University of AZ - Sarver Heart Center
Tucson, Arizona, 85724
United States
Cardiovascular Institute of San Diego
Chula Vista, California, 91911
United States
NorthBay Health, Heart and Vascular
Fairfield, California, 94533
United States
Mid Valley Cardiology - Fresno
Fresno, California, 93720
United States
South Orange County Cardiology Group
Laguna Hills, California, 92653
United States
University of Southern California - Keck School of Medicine
Los Angeles, California, 90033
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Valley Clinical Trials
Northridge, California, 91325
United States
Valley Clinical Trials
Pasadena, California, 91105
United States
Torrance Memorial Medical Center
Torrance, California, 90505
United States
Aurora Denver Cardiology Associates
Aurora, Colorado, 80012
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Heart Rhythm Solutions
Davie, Florida, 33328
United States
Florida Memorial Hospital
Jacksonville, Florida, 32216
United States
Florida Cardiology
Orlando, Florida, 32792
United States
Florida Heart Rhythm Specialist
Plantation, Florida, 33324
United States
Piedmont Heart
Atlanta, Georgia, 30309
United States
Redmond Regional Medical Center
Rome, Georgia, 30165
United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
United States
OSF Healthcare Cardiovascular Institute
Peoria, Illinois, 61614
United States
OSF HealthCare Cardiovascular Institute
Rockford, Illinois, 61107
United States
OSF Healthcare Cardiovascular Institute
Urbana, Illinois, 61801
United States
Franciscan Physician Network
Indianapolis, Indiana, 46237
United States
Ascension St. Vincent
Indianapolis, Indiana, 46260
United States
Community Healthcare System
Munster, Indiana, 46321
United States
Baptist Lexington
Lexington, Kentucky, 40503
United States
University of Kentucky - Gill Heart & Vascular Institute Clinical Research
Lexington, Kentucky, 40536
United States
Massachusetts General Hospital
Boston, Massachusetts, 02241
United States
Ascension Providence Park Hospital
Novi, Michigan, 38374
United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341
United States
Downriver Heart and Vascular
Southgate, Michigan, 48195
United States
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48197
United States
Minneapolis Heart Institute Foundation - Allina
Minneapolis, Minnesota, 55407
United States
St. Louis Heart and Vascular
Bridgeton, Missouri, 63044
United States
Logan Health
Kalispell, Montana, 59901
United States
Cooper Hospital
Haddon Heights, New Jersey, 08035
United States
Virtua Health - Our Lady of Lourdes
Marlton, New Jersey, 08053
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Rutgers Medical School
Newark, New Jersey, 07719
United States
Valley Hospital
Ridgewood, New Jersey, 07450
United States
Mount Sinai Morningside
New York, New York, 10025
United States
Mission Health
Asheville, North Carolina, 28801
United States
Atrium Health
Charlotte, North Carolina, 28204
United States
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
United States
TriHealth Hatton
Cincinnati, Ohio, 45242
United States
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, 44106
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Mount Carmel Research institute
Columbus, Ohio, 43213
United States
Regional Cardiac Arrythmia Inc.
Steubenville, Ohio, 43952
United States
ProMedica Health Systems
Toledo, Ohio, 43606
United States
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608
United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
United States
St. Luke's University Health Network
Allentown, Pennsylvania, 18104
United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
United States
UPMC Pinnacle Health
Harrisburg, Pennsylvania, 17011
United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Penn Medicine Lancaster General Hospital
Lancaster, Pennsylvania, 17602
United States
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, 19067
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Penn Presybyterian Medical Center
Philadelphia, Pennsylvania, 19104
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
UPMC Heart and Vascular Institute
Pittsburgh, Pennsylvania, 15213
United States
Reading Hospital
Reading, Pennsylvania, 19611
United States
Cardiovascular Consultants of Philadelphia
Yardley, Pennsylvania, 19067
United States
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
United States
VA North Texas Medical Center
Dallas, Texas, 75216
United States
Texan Procedure Center
El Paso, Texas, 79915
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
UT Health - Memorial Hermann Hospital
Houston, Texas, 77030
United States
Heart and Rhythm Institute of South Texas
San Antonio, Texas, 78229
United States
UT Health San Antonio
San Antonio, Texas, 78229
United States
CHRISTUS Trinity Clinic Research
Tyler, Texas, 75702
United States
Centra Health- Lynchburg General Hospital
Lynchburg, Virginia, 24501
United States
Bon Secours St. Mary's Hospital
Midlothian, Virginia, 23114
United States
HCA Chippenham Hospital
Richmond, Virginia, 23225
United States
Richmond VA Medical Center
Richmond, Virginia, 23249
United States
CAMC Clinical Trials Center
Charleston, West Virginia, 25304
United States
Marshall Cardiology
Huntington, West Virginia, 25701
United States
Aurora Research Institute
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Impulse Dynamics

  • Rami Kahwash, MD, STUDY_DIRECTOR, Ohio State University
  • Raul Weiss, MD, STUDY_DIRECTOR, Mt. Sinai Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-21
Study Completion Date2028-07

Study Record Updates

Study Start Date2020-01-21
Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

  • OPTIMIZER
  • Heart Failure
  • CCM
  • Post-Approval Study
  • NYHA class III
  • FIX-HF-5C
  • Chronic heart failure
  • Ejection fraction between 25 and 45
  • cardiac contractility modulation

Additional Relevant MeSH Terms

  • Heart Failure