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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102437
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : January 14, 2020
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
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
Actual Primary Completion Date : November 29, 2019
Actual Study Completion Date : November 29, 2019

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



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.


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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 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.
  7. Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater.
  8. Subjects who have had a myocardial infarction within 90 days of enrollment.
  9. Subjects who have mechanical tricuspid valve.
  10. Subjects who have a Left Ventricular Assist Device or prior heart transplant.
  11. Subjects on dialysis.
  12. Subjects who are participating in another experimental protocol.
  13. 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


Locations
Show Show 17 study locations
Sponsors and Collaborators
Impulse Dynamics
Investigators
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Study Director: Daniel Burkhoff, MD, PhD Impulse Dynamics
Publications:
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Responsible Party: Impulse Dynamics
ClinicalTrials.gov Identifier: NCT03102437    
Other Study ID Numbers: CP OPT2017-004
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Impulse Dynamics:
Cardiac Contractility Modulation
CCM
FIX-HF-5CA
Continued Access
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases