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

NCT03970343 · tracked via the Priya Life Science USA tracker

Sponsor

Impulse Dynamics

Phase

Observational

Started

2020-01-21

Last updated

2025-11-20

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

OPTIMIZER Smart System

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

Study 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%

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

Incidence of procedure and device-related complications — 1 year
Demonstrate, in the post-approval setting, that the OPTIMIZER Smart is safe to use, by assessing the rate of procedure related complications (30 days) and device related complications (1-year)
All-cause mortality — 3 years
Observed mortality will be compared to the predicted mortality according to the Seattle Heart Failure Model (SHFM) at 1 year and 3 years post-implant
Procedure related complications — 30-days
Procedure related complications through the end of 30 days following the index procedure

Trial sites (90)

Facility	City	Region
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
Redmond Regional Medical Center	Rome	Georgia
Advocate Illinois Masonic Medical Center	Chicago	Illinois
Advocate Good Samaritan Hospital	Downers Grove	Illinois
OSF Healthcare Cardiovascular Institute	Peoria	Illinois
OSF HealthCare Cardiovascular Institute	Rockford	Illinois
OSF Healthcare Cardiovascular Institute	Urbana	Illinois
Franciscan Physician Network	Indianapolis	Indiana
Ascension St. Vincent	Indianapolis	Indiana
Community Healthcare System	Munster	Indiana
Baptist Lexington	Lexington	Kentucky
University of Kentucky - Gill Heart & Vascular Institute Clinical Research	Lexington	Kentucky
Massachusetts General Hospital	Boston	Massachusetts
Ascension Providence Park Hospital	Novi	Michigan
St. Joseph Mercy Oakland	Pontiac	Michigan
Downriver Heart and Vascular	Southgate	Michigan

+ 50 more sites — see the full list on the official registry below.

More Impulse Dynamics trials in the USA

CCM OPEN HF Registry Recruiting

Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure Recruiting

Assessment of Combined CCM and ICD Device in HFrEF Active, not recruiting

Assessment of CCM in HF With Higher Ejection Fraction Recruiting

Other trials for the same condition

Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study) Enrolling by invitation

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients Active, not recruiting

MediBeacon® Transdermal GFR System for the Evaluation of Kidney Function in Adults With Heart Failure Recruiting

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting

XVIVO Heart Box (XHB) With Supplemented XVIVO Heart Solution (SXHS) Continued Access Protocol (CAP) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03970343 on ClinicalTrials.gov ↗ ← All trials in the USA