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

April 9, 2024 updated by: Impulse Dynamics

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

620

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • CardioVascular Associates of Mesa (CVAM)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ambrose Panico, MD
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • Chan Heart Rhythm Institute (CHRI)
        • Contact:
        • Principal Investigator:
          • Rodrigo Chan, MD
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • Southwest Cardiovascular Associates
        • Contact:
        • Principal Investigator:
          • Charles Jost, MD
        • Contact:
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Banner University Medical Center
        • Principal Investigator:
          • Radha Gopalan, MD
        • Contact:
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Arizona Cardiovascular Research Center
        • Principal Investigator:
          • Vijendra Swarup, MD
        • Contact:
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Cardiovascular Society of Arizona
        • Contact:
        • Principal Investigator:
          • Nathan Laufer, MD
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • Honor Health
        • Principal Investigator:
          • Thomas Mattioni, MD
        • Contact:
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of AZ - Sarver Heart Center
        • Contact:
        • Principal Investigator:
          • Mathew Hutchinson, MD
      • Tucson, Arizona, United States, 85712
    • California
      • Chula Vista, California, United States, 91911
        • Recruiting
        • Cardiovascular Institute of San Diego
        • Principal Investigator:
          • Burhan Mohamedali, MD
        • Sub-Investigator:
          • Steven Carlson, MD
        • Contact:
      • Fairfield, California, United States, 94533
        • Recruiting
        • NorthBay Health, Heart and Vascular
        • Contact:
        • Principal Investigator:
          • Milind Dhond, MD
      • Fresno, California, United States, 93720
        • Recruiting
        • Mid Valley Cardiology - Fresno
        • Contact:
        • Principal Investigator:
          • Michael L Krueger, DO
      • Laguna Hills, California, United States, 92653
        • Recruiting
        • South Orange County Cardiology Group
        • Contact:
        • Principal Investigator:
          • Daniel La Mont, MD
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Lawrence Czer, MD
        • Contact:
        • Contact:
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California - Keck School of Medicine
        • Contact:
        • Principal Investigator:
          • Andrew Zadeh, MD
      • Northridge, California, United States, 91325
        • Recruiting
        • Valley Clinical Trials
        • Principal Investigator:
          • Mehrdad Ariani, MD
        • Contact:
      • Pasadena, California, United States, 91105
      • Torrance, California, United States, 90505
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Aurora Denver Cardiology Associates
        • Contact:
        • Principal Investigator:
          • Chris Porterfield, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Not yet recruiting
        • MedStar Washington Hospital Center
        • Contact:
        • Principal Investigator:
          • David Strouse, MD
    • Florida
      • Davie, Florida, United States, 33328
        • Recruiting
        • Heart Rhythm Solutions
        • Contact:
        • Principal Investigator:
          • Awais Humayun, MD
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Florida Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Robert J. Kim, MD
      • Naples, Florida, United States, 34119
        • Completed
        • Naples Heart Rhythm Specialists
      • Orlando, Florida, United States, 32792
        • Recruiting
        • Florida Cardiology
        • Contact:
        • Principal Investigator:
          • Usman Siddiqui, MD
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Florida Heart Rhythm Specialist
        • Contact:
        • Principal Investigator:
          • David Kenigsberg, MD
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Completed
        • Piedmont Heart
      • Rome, Georgia, United States, 30165
        • Recruiting
        • Redmond Regional Medical Center
        • Principal Investigator:
          • Robert Styperek, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Completed
        • Advocate Illinois Masonic Medical Center
      • Downers Grove, Illinois, United States, 60515
        • Completed
        • Advocate Good Samaritan Hospital
      • Peoria, Illinois, United States, 61614
        • Recruiting
        • OSF HealthCare Cardiovascular Institute
        • Contact:
        • Principal Investigator:
          • Amit Mehrotra, MD
      • Rockford, Illinois, United States, 61107
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • OSF HealthCare Cardiovascular Institute
        • Contact:
        • Principal Investigator:
          • Abraham Kocheril, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension St. Vincent
        • Principal Investigator:
          • Amit C. Patel, MD
        • Contact:
      • Indianapolis, Indiana, United States, 46237
      • Munster, Indiana, United States, 46321
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Lexington
        • Principal Investigator:
          • Gery Tomassoni, MD
        • Sub-Investigator:
          • Craig McCotter, MD
        • Sub-Investigator:
          • Johan Aasbo, MD
        • Contact:
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky - Gill Heart & Vascular Institute Clinical Research
        • Contact:
        • Principal Investigator:
          • Aaron Hesselson, MD
        • Sub-Investigator:
          • Karen Ellison, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02241
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Theofanie Mela, MD
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Completed
        • Sparrow Clinical Research Institute
      • Novi, Michigan, United States, 38374
        • Recruiting
        • Ascension Providence Park Hospital
        • Contact:
        • Principal Investigator:
          • Nathan Foster, MD
      • Pontiac, Michigan, United States, 48341
        • Completed
        • St. Joseph Mercy Oakland
      • Rochester, Michigan, United States, 48307
        • Recruiting
        • Ascension Providence Rochester
        • Contact:
        • Principal Investigator:
          • Madar Abed, MD
      • Southgate, Michigan, United States, 48195
        • Recruiting
        • Downriver Heart and Vascular
        • Contact:
        • Principal Investigator:
          • Qaiser Shafiq, MD
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health Michigan Heart
        • Contact:
        • Principal Investigator:
          • Jihn Han, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation - Allina
        • Principal Investigator:
          • Jay Sengupta, MD
        • Contact:
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Recruiting
        • St. Louis Heart and Vascular
        • Principal Investigator:
          • Rafiq Ramadan, MD
        • Contact:
    • Montana
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Logan Health
        • Contact:
        • Principal Investigator:
          • Eve Gillespie, MD
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
        • Recruiting
        • Cooper Hospital
        • Principal Investigator:
          • George Mark, MD
        • Contact:
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • Virtua Health - Our Lady of Lourdes
        • Contact:
        • Principal Investigator:
          • Heath Saltzman, MD
        • Sub-Investigator:
          • Darius Sholevar, MD
        • Sub-Investigator:
          • George Mark, MD
        • Sub-Investigator:
          • Steven Levi, MD
        • Sub-Investigator:
          • Matthew Sandler, MD
      • Morristown, New Jersey, United States, 07960
      • Neptune, New Jersey, United States, 07753
        • Completed
        • Jersey Shore University Medical Center
      • Newark, New Jersey, United States, 07719
        • Recruiting
        • Rutgers Medical School
        • Contact:
        • Principal Investigator:
          • Emad Aziz, MD
        • Sub-Investigator:
          • Alfonso Waller, MD
      • Ridgewood, New Jersey, United States, 07450
    • New York
      • New York, New York, United States, 10025
        • Recruiting
        • Mount Sinai Morningside
        • Contact:
        • Principal Investigator:
          • Ranjit Suri, MD
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Charlotte, North Carolina, United States, 28204
      • Raleigh, North Carolina, United States, 27607
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • TriHealth Hatton
        • Principal Investigator:
          • Dilesh Patel, MD
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals of Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Ivan Cakulev, MD
      • Columbus, Ohio, United States, 43210
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Mount Carmel Research institute
        • Contact:
        • Principal Investigator:
          • Lee Gemma, MD
      • Steubenville, Ohio, United States, 43952
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • ProMedica Health Systems
        • Contact:
        • Principal Investigator:
          • Jack Li, MD
      • Toledo, Ohio, United States, 43608
        • Recruiting
        • Mercy Health - St. Vincent Medical Center
        • Contact:
        • Principal Investigator:
          • Ameer Kabour, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Oklahoma Heart Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Charles Te, MD
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Recruiting
        • Bryn Mawr Hospital
        • Principal Investigator:
          • Sheetal Chandhok, MD
        • Contact:
      • Harrisburg, Pennsylvania, United States, 17011
        • Recruiting
        • UPMC Pinnacle Health
        • Principal Investigator:
          • Roberto Hodara, MD
        • Contact:
        • Contact:
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Milton S. Hershey Medical Center
        • Principal Investigator:
          • Howard Eisen, MD
        • Contact:
      • Lancaster, Pennsylvania, United States, 17602
        • Recruiting
        • Penn Medicine Lancaster General Hospital
        • Contact:
        • Principal Investigator:
          • Matthew Bernabei, MD
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital
        • Contact:
        • Principal Investigator:
          • Isaac Whitman, MD
        • Sub-Investigator:
          • Anju Basil, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19141
        • Recruiting
        • Einstein Medical Center
        • Contact:
        • Principal Investigator:
          • Sumeet Mainigi, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19067
        • Recruiting
        • Cardiology Consultants of Philadelphia
        • Contact:
        • Principal Investigator:
          • Christopher Schulze, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Completed
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Contact:
        • Principal Investigator:
          • Matthew Lander, MD
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Heart and Vascular Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandeep Jain, MD
      • Reading, Pennsylvania, United States, 19611
      • Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Hospital | Tower Health
        • Principal Investigator:
          • Jared Green, MD
        • Contact:
      • Yardley, Pennsylvania, United States, 19067
        • Recruiting
        • Cardiovascular Consultants of Philadelphia
        • Contact:
        • Principal Investigator:
          • Christopher Schulze, MD
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Cardiac Arrhythmia Research
        • Principal Investigator:
          • Robert Canby, MD
        • Contact:
      • Dallas, Texas, United States, 75216
        • Recruiting
        • VA North Texas Medical Center
        • Contact:
        • Principal Investigator:
          • Phi Wiegn, MD
        • Contact:
      • El Paso, Texas, United States, 79915
        • Recruiting
        • Texan Procedure Center
        • Contact:
        • Principal Investigator:
          • Ali Nasur, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College Of Medicine
        • Principal Investigator:
          • Mihail Chelu, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Health - Memorial Hermann Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anju Bhardwaj, MD
      • San Antonio, Texas, United States, 78229
        • Completed
        • Heart and Rhythm Institute of South Texas
      • Tyler, Texas, United States, 75702
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Recruiting
        • Centra Health- Lynchburg General Hospital
        • Principal Investigator:
          • Matthew Sackett, MD
        • Contact:
      • Lynchburg, Virginia, United States, 24501
        • Recruiting
        • Centra Health - Lynchburg General Hospital
        • Principal Investigator:
          • Matthew Sackett, MD
        • Contact:
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours St. Mary's Hospital
        • Principal Investigator:
          • Harpreet Grewal, MD
        • Contact:
      • Richmond, Virginia, United States, 23225
        • Recruiting
        • HCA Chippenham Hospital
        • Contact:
        • Principal Investigator:
          • Guru Mohanty, MD
      • Richmond, Virginia, United States, 23249
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Completed
        • CAMC Clinical Trials Center
      • Huntington, West Virginia, United States, 25701
        • Recruiting
        • Marshall Cardiology
        • Contact:
        • Principal Investigator:
          • Carlos Rueda, MD
        • Sub-Investigator:
          • Paul Okhumale, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Imran Niazi, MD
        • Sub-Investigator:
          • Mohamed Hani, MD
        • Sub-Investigator:
          • Jodi Zilinski, MD
        • Sub-Investigator:
          • Mohammad Mortada, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of procedure and device-related complications
Time Frame: 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)
1 year
All-cause mortality
Time Frame: 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
3 years
Procedure related complications
Time Frame: 30-days
Procedure related complications through the end of 30 days following the index procedure
30-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular hospitalizations
Time Frame: 2 years
Change in cardiovascular hospitalization rate and HF hospitalization rate from 1-year prior to 2 years following index implantation
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Impulse Dynamics

Investigators

  • Study Director: Rami Kahwash, MD, The Ohio State University Wexner Medical Center
  • Study Director: Raul Weiss, MD, 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 Major Dates

Study Start (Actual)

January 21, 2020

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

May 30, 2019

First Posted (Actual)

May 31, 2019

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA_CP_307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on OPTIMIZER Smart System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe