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Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System (FIX-HF-5CA)

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ClinicalTrials.gov Identifier: NCT03102437
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Impulse Dynamics

Brief Summary:
This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.

Condition or disease Intervention/treatment Phase
Heart Failure Congestive Heart Failure Chronic Heart Disease CHF Device: Optimizer Smart System Not Applicable

Detailed Description:
The Continued Access study is a prospective, non-randomized, multi-center study designed to allow controlled access to the Optimizer Smart System until the PMA order has been issued by the FDA.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Continued Access
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FIX-HF-5CA: Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : August 15, 2018
Estimated Study Completion Date : August 15, 2018

Arm Intervention/treatment
Experimental: Optimizer Smart System
All eligible subjects will have the Optimizer Smart System implanted and receive cardiac contractility modulation therapy (CCM).
Device: Optimizer Smart System
The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.




Primary Outcome Measures :
  1. SADEs [ Time Frame: 6 Months ]
    Serious Adverse Device Events


Secondary Outcome Measures :
  1. KCCQ [ Time Frame: 6 Months ]
    Kansas City Cardiomyopathy Questionnaire

  2. NYHA [ Time Frame: 6 Months ]
    New York Heart Association classification



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects who are 18 years of age or older
  2. Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography.
  3. Subjects who, in the opinion of the Investigator (based on the current guidelines for clinical practice), have been treated for heart failure for at least 90 days and are currently receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure.
  4. Subjects who are in New York Heart Association functional Class III and IV at the time of enrollment.
  5. Subjects who are willing and able to return for all follow-up visits.

Exclusion Criteria:

  1. Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
  2. Subjects receiving any form of inotropic support within 30 days before enrollment, including subjects on continuous IV inotrope therapy.
  3. Subjects hospitalized for decompensated heart failure requiring acute treatment with intravenous loop diuretics, IV inotropes or hemofiltration within 30 days before enrollment and baseline testing.
  4. Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring.
  5. Subjects having a PR interval greater than 375ms.
  6. Subjects who have chronic (permanent or persistent) atrial fibrillation or atrial flutter or those cardioverted within 30 days of enrollment.
  7. Subjects who are scheduled for a CABG or a PTCA procedure, or who have undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.
  8. Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater.
  9. Subjects who have had a myocardial infarction within 90 days of enrollment.
  10. Subjects who have mechanical tricuspid valve.
  11. Subjects who have a Left Ventricular Assist Device or prior heart transplant.
  12. Subjects on dialysis.
  13. Subjects who are participating in another experimental protocol.
  14. Subjects who are unable to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102437


Contacts
Contact: Angela Stagg 845-359-2389 ext 206 angelas@impulse-dynamics.com

Locations
United States, Arizona
Chan Heart Rhythm Institute Recruiting
Mesa, Arizona, United States, 85206
Contact: Rachelle Westerfield    602-460-5390    Rachelle@chanheartrhythm.com   
Principal Investigator: Rodrigo Chan, MD         
Southwest Cardiology Associates Recruiting
Mesa, Arizona, United States, 85206
Contact: Rachelle Westerfield    602-460-5390    r.westerfield@impulse-dynamics.com   
Principal Investigator: Charles Jost, MD         
Cardiovascular Consultants Recruiting
Phoenix, Arizona, United States, 85027
Contact: Carrie Saglam    602-652-8761 ext 4305    csaglam@cvcheart.com   
Principal Investigator: Andy Tran, MD         
Arizona Arrhythmia Consultants Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Patty Williams    480-323-1046    Patty.Williams@HonorHealth.com   
Principal Investigator: Thomas Mattioni, MD         
Pima Heart Recruiting
Tucson, Arizona, United States, 85745
Contact: Ellen Horn    520-465-1849    EllenH@pimaheart.com   
Principal Investigator: Darren F. Peress, MD         
Sub-Investigator: Jose J. Fernandez, MD         
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Kristie Schneider    859-260-6429    Kschneid@bhsi.com   
Principal Investigator: Gery Tomassoni, MD         
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Laura True    859-218-1644    lauratrue@uky.edu   
Principal Investigator: Aaron Hesselson, MD         
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Angela Smith    504-703-2061    anglsmith@ochsner.org   
Contact: Monique Pellegrin    504-842-2690    mopellegrin@ochsner.org   
Principal Investigator: Freddy Abi-Samra, MD         
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Julie Field    856-669-8847    Field-Julie@CooperHealth.edu   
Principal Investigator: Andrea Russo, MD         
United States, Ohio
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Shawna Oxier    614-247-6797    Shawna.oxier@osumc.edu   
Principal Investigator: Rami Kahwash, MD         
United States, Pennsylvania
St. Mary Research Institute Recruiting
Langhorne, Pennsylvania, United States, 19047
Contact: Marci Petrino    215-710-4586    mpetrino@stmaryhealthcare.org   
Contact: Kimberly Devine    215-710-4585    kdevine@stmaryhealthcare.org   
Principal Investigator: Heath Saltzman, MD         
Jefferson Heart Institute Recruiting
Philadelphia, Pennsylvania, United States, 19047
Contact: Amy Locasio    215-710-2000    amy.locasio@jefferson.edu   
Contact: Kimberly Wittenberg    215-710-2000    kimberly.wittenberg@jefferson.edu   
Principal Investigator: Steven Roberts, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Cosette Motta    215-662-4214    Cosette.Motta@uphs.upenn.edu   
Principal Investigator: Ross Zimmer, MD         
Penn Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Caitlin Shoemaker    215-662-8562    Caitlin.Shoemaker@uphs.upenn.edu   
Principal Investigator: Ross Zimmer, MD         
Guthrie Medical Group at Robert Packer Hospital Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Donna Tyburczy    570-887-6071    donna.tyburczy@guthrie.org   
Principal Investigator: Pramod Deshmukh, MD         
United States, Texas
CHRISTUS Trinity Mother Frances Health System Recruiting
Tyler, Texas, United States, 75701
Contact: Carol Cushman    903-606-8846    Carol.Cushman@tmfhc.org   
Contact: Courtney Yotter    903-606-1621    Courtney.Yotter@tmfhc.org   
Principal Investigator: Stan Weiner, MD         
Sponsors and Collaborators
Impulse Dynamics
Investigators
Study Director: Daniel Burkhoff, MD, PhD Impulse Dynamics

Publications:
Responsible Party: Impulse Dynamics
ClinicalTrials.gov Identifier: NCT03102437     History of Changes
Other Study ID Numbers: CP OPT2017-004
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Impulse Dynamics:
Cardiac Contractility Modulation
CCM
FIX-HF-5CA
Continued Access

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases