Clinical trial NCT03970343: Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: 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
Lead sponsor: Impulse Dynamics
Sponsor class: INDUSTRY
First posted: 2019-05-31
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will represent a patient population with stable, systolic left ventricular dysfunction and moderate symptomatic heart failure despite guideline-directed medical therapy.

Brief 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%

Detailed description: The Impulse Dynamics OPTIMIZER Smart Pre-Market Application (PMA) clinical data confirmed that CCM therapy delivered with the Optimizer meaningfully improved health outcomes in patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45%. CCM has shown significant improvements in quality of life measures, with an average improvement of \>11 points in MLHWFQ incremental to the improvement of a randomized control group with no device. Six minute hall walk and functional class also showed improvements in the PMA data. The post-approval study (PAS) protocol has been designed to evaluate long term safety and efficacy of the OPTIMIZER Smart in a real-world setting.

Eligibility criteria: Inclusion Criteria:

1. Patient provides written authorization and/or consent per institution and geographical requirements
2. Male or non-pregnant female, aged 18 or older
3. Left ventricular ejection fraction of 25-45% (inclusive, per site assessment)
4. NYHA Class III heart failure symptoms
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. Patient has been treated with guideline-directed medical therapy

Exclusion Criteria:

1. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
2. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
3. Myocardial infarction within 90 days prior to implant
4. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
5. Prior heart transplant or ventricular assist device
6. Mechanical tricuspid valve
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. Participating in a cardiac investigational study at the same time
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.

Primary outcomes:
measure: Incidence of procedure and device-related complications
timeFrame: 1 year
measure: All-cause mortality
timeFrame: 3 years
measure: Procedure related complications
timeFrame: 30-days
Secondary outcomes:
measure: Cardiovascular hospitalizations
timeFrame: 2 years
Other outcomes:
Locations:
city: Mesa
country: United States
facility: CardioVascular Associates of Mesa (CVAM)
state: Arizona
city: Mesa
country: United States
facility: Chan Heart Rhythm Institute (CHRI)
state: Arizona
city: Mesa
country: United States
facility: Southwest Cardiovascular Associates
state: Arizona
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Cardiovascular Society of Arizona
state: Arizona
city: Phoenix
country: United States
facility: Arizona Cardiovascular Research Center
state: Arizona
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Tucson
country: United States
facility: Pima Heart and Vascular Research Center
state: Arizona
city: Tucson
country: United States
facility: University of AZ - Sarver Heart Center
state: Arizona
city: Chula Vista
country: United States
facility: Cardiovascular Institute of San Diego
state: California
city: Fairfield
country: United States
facility: NorthBay Health, Heart and Vascular
state: California
city: Fresno
country: United States
facility: Mid Valley Cardiology - Fresno
state: California
city: Laguna Hills
country: United States
facility: South Orange County Cardiology Group
state: California
city: Los Angeles
country: United States
facility: University of Southern California - Keck School of Medicine
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials
state: California
city: Pasadena
country: United States
facility: Valley Clinical Trials
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Davie
country: United States
facility: Heart Rhythm Solutions
state: Florida
city: Jacksonville
country: United States
facility: Florida Memorial Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Cardiology
state: Florida
city: Plantation
country: United States
facility: Florida Heart Rhythm Specialist
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center
state: Illinois
city: Downers Grove
country: United States
facility: Advocate Good Samaritan Hospital
state: Illinois
city: Peoria
country: United States
facility: OSF Healthcare Cardiovascular Institute
state: Illinois
city: Rockford
country: United States
facility: OSF HealthCare Cardiovascular Institute
state: Illinois
city: Urbana
country: United States
facility: OSF Healthcare Cardiovascular Institute
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan Physician Network
state: Indiana
city: Indianapolis
country: United States
facility: Ascension St. Vincent
state: Indiana
city: Munster
country: United States
facility: Community Healthcare System
state: Indiana
city: Lexington
country: United States
facility: Baptist Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky - Gill Heart & Vascular Institute Clinical Research
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Novi
country: United States
facility: Ascension Providence Park Hospital
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland
state: Michigan
city: Rochester
country: United States
facility: Ascension Providence Rochester
state: Michigan
city: Southgate
country: United States
facility: Downriver Heart and Vascular
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health Michigan Heart
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation - Allina
state: Minnesota
city: Bridgeton
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Kalispell
country: United States
facility: Logan Health
state: Montana
city: Haddon Heights
country: United States
facility: Cooper Hospital
state: New Jersey
city: Marlton
country: United States
facility: Virtua Health - Our Lady of Lourdes
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Newark
country: United States
facility: Rutgers Medical School
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Morningside
state: New York
city: Asheville
country: United States
facility: Mission Health
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Cincinnati
country: United States
facility: TriHealth Hatton
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel Research institute
state: Ohio
city: Steubenville
country: United States
facility: Regional Cardiac Arrythmia Inc.
state: Ohio
city: Toledo
country: United States
facility: ProMedica Health Systems
state: Ohio
city: Toledo
country: United States
facility: Mercy Health - St. Vincent Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Allentown
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: UPMC Pinnacle Health
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Penn Medicine Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presybyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Heart and Vascular Institute
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
city: Yardley
country: United States
facility: Cardiovascular Consultants of Philadelphia
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Dallas
country: United States
facility: VA North Texas Medical Center
state: Texas
city: El Paso
country: United States
facility: Texan Procedure Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: UT Health - Memorial Hermann Hospital
state: Texas
city: San Antonio
country: United States
facility: Heart and Rhythm Institute of South Texas
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: Tyler
country: United States
facility: CHRISTUS Trinity Clinic Research
state: Texas
city: Lynchburg
country: United States
facility: Centra Health- Lynchburg General Hospital
state: Virginia
city: Midlothian
country: United States
facility: Bon Secours St. Mary's Hospital
state: Virginia
city: Richmond
country: United States
facility: HCA Chippenham Hospital
state: Virginia
city: Richmond
country: United States
facility: Richmond VA Medical Center
state: Virginia
city: Charleston
country: United States
facility: CAMC Clinical Trials Center
state: West Virginia
city: Huntington
country: United States
facility: Marshall Cardiology
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora Research Institute
state: Wisconsin
Study officials:
affiliation: Ohio State University
name: Rami Kahwash, MD
role: STUDY_DIRECTOR
affiliation: Mt. Sinai Miami
name: Raul Weiss, MD
role: STUDY_DIRECTOR
References: