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NCT03970343 Clinical Trial

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

Heart Failure Clinical Trial

— PAS  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03970343
Other study ID # CA_CP_307
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 21, 2020
Est. completion date March 1, 2026

Study information
Verified date April 2024
Source Impulse Dynamics
Contact Jozef Murar
Phone 856-642-9933
Email jmurar@impulsedynamics.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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%

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 620
Est. completion date March 1, 2026
Est. primary completion date March 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• OPTIMIZER Smart System
Eligible subjects will receive the OPTIMIZER Smart, which is comprised of three major components: Optimizer Smart or Optimizer Smart Mini Vesta Charger or Guardio Charger Two commercially available intravascular leads

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

Sponsors (1)
Lead Sponsor Collaborator
Impulse Dynamics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of procedure and device-related complications 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) 1 year
Primary All-cause mortality 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 3 years
Primary Procedure related complications Procedure related complications through the end of 30 days following the index procedure 30-days
Secondary Cardiovascular hospitalizations Change in cardiovascular hospitalization rate and HF hospitalization rate from 1-year prior to 2 years following index implantation 2 years
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