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

This study is currently recruiting participants.
Verified November 2017 by Impulse Dynamics
Sponsor:
ClinicalTrials.gov Identifier:
NCT03102437
First Posted: April 5, 2017
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Impulse Dynamics
  Purpose
This is a multicenter, prospective, single-arm Continued Access study of the Optimizer Smart System with CCM therapy.

Condition Intervention
Heart Failure Congestive Heart Failure Chronic Heart Disease CHF Device: Optimizer Smart System

Study Type: Interventional
Study Design: 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%

Further study details as provided by Impulse Dynamics:

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


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

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


Estimated Enrollment: 250
Actual Study Start Date: July 1, 2017
Estimated Study Completion Date: April 15, 2018
Estimated Primary Completion Date: April 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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         
Cardiovascular Consultants Recruiting
Phoenix, Arizona, United States, 85027
Contact: Carrie Saglam    602-652-8761 ext 4305    csaglam@cvcheart.com   
Principal Investigator: Andy Tran, MD         
Pima Heart Not yet recruiting
Tucson, Arizona, United States, 85745
Contact: Ellen Horn    520-465-1849    ellenh@pimaheart.com   
Principal Investigator: Alexandre Benjo, MD         
Sub-Investigator: Darren Peress, 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         
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, Pennsylvania
Thomas Jefferson University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19152
Contact: Amy Locascio         
Principal Investigator: Steven Roberts, 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
  More Information

Publications:
Responsible Party: Impulse Dynamics
ClinicalTrials.gov Identifier: NCT03102437     History of Changes
Other Study ID Numbers: CP OPT2017-004
First Submitted: March 23, 2017
First Posted: April 5, 2017
Last Update Posted: November 17, 2017
Last Verified: November 2017
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