ClinicalTrials.gov record
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
ClinicalTrials.gov ID: NCT03970343
Public ClinicalTrials.gov record NCT03970343. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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%
Study identification
- NCT ID
- NCT03970343
- Recruitment status
- Active, not recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 620 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 20, 2020
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2028
- Last update posted
- Nov 19, 2025
2020 – 2028
United States locations
- U.S. sites
- 90
- U.S. states
- 24
- U.S. cities
- 72
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CardioVascular Associates of Mesa (CVAM) | Mesa | Arizona | 85206 | — |
| Chan Heart Rhythm Institute (CHRI) | Mesa | Arizona | 85206 | — |
| Southwest Cardiovascular Associates | Mesa | Arizona | 85206 | — |
| Banner University Medical Center | Phoenix | Arizona | 85006 | — |
| Cardiovascular Society of Arizona | Phoenix | Arizona | 85006 | — |
| Arizona Cardiovascular Research Center | Phoenix | Arizona | 85016 | — |
| Honor Health | Scottsdale | Arizona | 85258 | — |
| Pima Heart and Vascular Research Center | Tucson | Arizona | 85712 | — |
| University of AZ - Sarver Heart Center | Tucson | Arizona | 85724 | — |
| Cardiovascular Institute of San Diego | Chula Vista | California | 91911 | — |
| NorthBay Health, Heart and Vascular | Fairfield | California | 94533 | — |
| Mid Valley Cardiology - Fresno | Fresno | California | 93720 | — |
| South Orange County Cardiology Group | Laguna Hills | California | 92653 | — |
| University of Southern California - Keck School of Medicine | Los Angeles | California | 90033 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Valley Clinical Trials | Northridge | California | 91325 | — |
| Valley Clinical Trials | Pasadena | California | 91105 | — |
| Torrance Memorial Medical Center | Torrance | California | 90505 | — |
| Aurora Denver Cardiology Associates | Aurora | Colorado | 80012 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Heart Rhythm Solutions | Davie | Florida | 33328 | — |
| Florida Memorial Hospital | Jacksonville | Florida | 32216 | — |
| Florida Cardiology | Orlando | Florida | 32792 | — |
| Florida Heart Rhythm Specialist | Plantation | Florida | 33324 | — |
| Piedmont Heart | Atlanta | Georgia | 30309 | — |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | — |
| Advocate Illinois Masonic Medical Center | Chicago | Illinois | 60657 | — |
| Advocate Good Samaritan Hospital | Downers Grove | Illinois | 60515 | — |
| OSF Healthcare Cardiovascular Institute | Peoria | Illinois | 61614 | — |
| OSF HealthCare Cardiovascular Institute | Rockford | Illinois | 61107 | — |
| OSF Healthcare Cardiovascular Institute | Urbana | Illinois | 61801 | — |
| Franciscan Physician Network | Indianapolis | Indiana | 46237 | — |
| Ascension St. Vincent | Indianapolis | Indiana | 46260 | — |
| Community Healthcare System | Munster | Indiana | 46321 | — |
| Baptist Lexington | Lexington | Kentucky | 40503 | — |
| University of Kentucky - Gill Heart & Vascular Institute Clinical Research | Lexington | Kentucky | 40536 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02241 | — |
| Ascension Providence Park Hospital | Novi | Michigan | 38374 | — |
| St. Joseph Mercy Oakland | Pontiac | Michigan | 48341 | — |
| Downriver Heart and Vascular | Southgate | Michigan | 48195 | — |
| Trinity Health Michigan Heart | Ypsilanti | Michigan | 48197 | — |
| Minneapolis Heart Institute Foundation - Allina | Minneapolis | Minnesota | 55407 | — |
| St. Louis Heart and Vascular | Bridgeton | Missouri | 63044 | — |
| Logan Health | Kalispell | Montana | 59901 | — |
| Cooper Hospital | Haddon Heights | New Jersey | 08035 | — |
| Virtua Health - Our Lady of Lourdes | Marlton | New Jersey | 08053 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Rutgers Medical School | Newark | New Jersey | 07719 | — |
| Valley Hospital | Ridgewood | New Jersey | 07450 | — |
| Mount Sinai Morningside | New York | New York | 10025 | — |
| Mission Health | Asheville | North Carolina | 28801 | — |
| Atrium Health | Charlotte | North Carolina | 28204 | — |
| NC Heart and Vascular Research | Raleigh | North Carolina | 27607 | — |
| TriHealth Hatton | Cincinnati | Ohio | 45242 | — |
| University Hospitals of Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Mount Carmel Research institute | Columbus | Ohio | 43213 | — |
| Regional Cardiac Arrythmia Inc. | Steubenville | Ohio | 43952 | — |
| ProMedica Health Systems | Toledo | Ohio | 43606 | — |
| Mercy Health - St. Vincent Medical Center | Toledo | Ohio | 43608 | — |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | — |
| St. Luke's University Health Network | Allentown | Pennsylvania | 18104 | — |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | — |
| UPMC Pinnacle Health | Harrisburg | Pennsylvania | 17011 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Penn Medicine Lancaster General Hospital | Lancaster | Pennsylvania | 17602 | — |
| Cardiology Consultants of Philadelphia | Philadelphia | Pennsylvania | 19067 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Penn Presybyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| UPMC Heart and Vascular Institute | Pittsburgh | Pennsylvania | 15213 | — |
| Reading Hospital | Reading | Pennsylvania | 19611 | — |
| Cardiovascular Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | — |
| Texas Cardiac Arrhythmia Research | Austin | Texas | 78705 | — |
| VA North Texas Medical Center | Dallas | Texas | 75216 | — |
| Texan Procedure Center | El Paso | Texas | 79915 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| UT Health - Memorial Hermann Hospital | Houston | Texas | 77030 | — |
| Heart and Rhythm Institute of South Texas | San Antonio | Texas | 78229 | — |
| UT Health San Antonio | San Antonio | Texas | 78229 | — |
| CHRISTUS Trinity Clinic Research | Tyler | Texas | 75702 | — |
| Centra Health- Lynchburg General Hospital | Lynchburg | Virginia | 24501 | — |
| Bon Secours St. Mary's Hospital | Midlothian | Virginia | 23114 | — |
| HCA Chippenham Hospital | Richmond | Virginia | 23225 | — |
| Richmond VA Medical Center | Richmond | Virginia | 23249 | — |
| CAMC Clinical Trials Center | Charleston | West Virginia | 25304 | — |
| Marshall Cardiology | Huntington | West Virginia | 25701 | — |
| Aurora Research Institute | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03970343, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 19, 2025 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03970343 live on ClinicalTrials.gov.