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Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C (FIX-HF-5C)

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: NCT01381172
Recruitment Status : Active, not recruiting
First Posted : June 27, 2011
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Impulse Dynamics

Brief Summary:
The objective of this investigation is to evaluate the safety and effectiveness of the OPTIMIZER® System in subjects with medically refractory moderate-to-severe heart failure.

Condition or disease Intervention/treatment Phase
NYHA Class III Heart Failure NYHA Class IV Heart Failure Device: Optimizer System Other: No intervention: Optimal medical therapy Not Applicable

Detailed Description:

The Impulse Dynamics FIX-HF-5C Study is a prospective, multicenter, randomized study to evaluate the safety and efficacy of cardiac contractility modulation (CCM) signals delivered by the implantable OPTIMIZER System in patients with NYHA class III and IV heart failure and an ejection fraction 25-45%. The study will involve the recruitment of 160 subjects at a total of up to 60 sites.

Those subjects who fulfill all inclusion and exclusion criteria based upon baseline test results will be randomly assigned in a 1:1 ratio to either the OPTIMIZER System plus optimal medical therapy (OMT) or to a control group receiving OMT alone. All randomized subjects will be followed for 24 weeks and shall receive the same study related assessments throughout the course of the study. In addition, all subjects will continue to receive OMT for the treatment of their heart failure. Mortality will be reported out to 2 years.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%: FIX-HF-5C
Study Start Date : January 2011
Actual Primary Completion Date : September 2017
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Treatment
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Device: Optimizer System
The OPTIMIZER 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.
Other Name: CCM therapy

Control
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
Other: No intervention: Optimal medical therapy
The control group receives optimal medical therapy only.




Primary Outcome Measures :
  1. Improvement in exercise tolerance [ Time Frame: 24 weeks ]
    Exercise tolerance quantified by peak VO2 measured with cardiopulmonary exercise stress testing (CPX)


Secondary Outcome Measures :
  1. MLWHFQ [ Time Frame: 24 weeks ]
    Quality of life, as assessed by the Minnesota Living with Heart Failure (MLWHF) Questionnaire

  2. Peak VO2 with respiratory exchange ratio (RER) [ Time Frame: 24 weeks ]
    Peak VO2 with change in respiratory exchange ratio (RER) included as a covariate.

  3. NYHA [ Time Frame: 24 weeks ]
    Heart failure class, as assessed by the New York Heart Association (NYHA) classification.

  4. peak VO2 with a peak RER of ≥1.05 [ Time Frame: 24 weeks ]
    Peak VO2 in an analysis that only includes tests with a peak RER of ≥1.05.


Other Outcome Measures:
  1. 6 Minute Hall Walk [ Time Frame: 24 weeks ]
    Distance walked in 6 minutes

  2. VE/VCO2 [ Time Frame: 24 weeks ]
    VE/VCO2 as measured during cardiopulmonary stress testing.



Information from the National Library of Medicine

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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 are either male or female. Females of childbearing potential must be using a medically approved method of birth control and must agree to continue to use birth control throughout the study, or must be surgically sterilized (tubal ligation, hysterectomy) or post-menopausal for at least 1 year.
  3. Condition

    1. Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography determined by the echocardiography core laboratory.
    2. Subjects who have been treated for heart failure for at least 90 days (including treatment with a β-blocker for at least 90 days unless the subject is intolerant) and are in New York Heart Association functional Class III and IV at the time of enrollment.
    3. Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure according to the region- specific guideline recommendations. For patients with EF≤35%, this regimen shall consist of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and β-blocker. Stable is defined as no more than a 100% increase or 50% decrease in dose.
    4. Subjects who, in the opinion of the Principal Investigator (based on the current guidelines for clinical practice ), have a clinical indication for an implanted cardiac defibrillator (ICD, e.g., EF≤35%) and/or pacemaker, must have an existing device or agree to undergo implantation of such a device unless the patient refuses to undergo the implantation of such device for personal reasons.
    5. Subjects who are willing and able to return for all follow-up visits.

Exclusion Criteria:

  1. Subjects whose baseline peak VO2 is <9 or >20 ml O2/min/kg.
  2. Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
  3. Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation.
  4. Subjects who have been hospitalized for heart failure which required the use of inotropic support within 30 days of enrollment.
  5. Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring.
  6. Subjects having a PR interval greater than 375 ms.
  7. Subjects who have chronic (permanent or persistent) atrial fibrillation or atrial flutter or those cardioverted within 30 days of enrollment.
  8. Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to perform baseline stress testing.
  9. 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.
  10. Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater.
  11. Subjects who have had a myocardial infarction within 90 days of enrollment.
  12. Subjects who have mechanical tricuspid valve.
  13. Subjects who have a prior heart transplant.
  14. Subjects on dialysis.
  15. Subjects who are participating in another experimental protocol.
  16. 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): NCT01381172


  Hide Study Locations
Locations
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United States, Arizona
Cardiovascular Consultants
Glendale, Arizona, United States, 85306
Cardiovascular Associates of Mesa
Mesa, Arizona, United States, 85206
Chan Heart Rhythm Institute
Mesa, Arizona, United States, 85206
Arizona Heart & Rhythm Center
Phoenix, Arizona, United States, 85013
Pima Heart
Tucson, Arizona, United States, 85712
University of Arizona Sarver Heart Center
Tucson, Arizona, United States, 85724
United States, California
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
United States, Connecticut
Yale - New Haven Hospital
New Haven, Connecticut, United States, 06519
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
Florida Hospital - Pepin Heart Institute
Tampa, Florida, United States, 33613
United States, Illinois
Advocate Medical Group - Midwest Heart Foundation
Naperville, Illinois, United States, 60540
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
St. Elizabeth's Medical Center
Brighton, Massachusetts, United States, 02135
United States, Michigan
Detroit Medical Center - Cardiovascular Institute
Detroit, Michigan, United States, 48201
United States, Nebraska
Nebraska Heart Institute
Lincoln, Nebraska, United States, 68526
Bryan Heart LGH
Lincoln, Nebraska, United States, 69506
United States, New Jersey
UMDNJ
Newark, New Jersey, United States, 07103
United States, New York
Mt. Sinai Medical Center
New York, New York, United States, 10029
United States, Ohio
The Lindner Center
Cincinnati, Ohio, United States, 45219
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Guthrie Medical Group
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Stern Cardiovascular Foundation
Germantown, Tennessee, United States, 38138
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Trinity Clinic
Tyler, Texas, United States, 75701
United States, Virginia
Inova Heart & Vascular Institute
Falls Church, Virginia, United States, 22042
United States, Wisconsin
Aurora Health Care
Milwaukee, Wisconsin, United States, 53215
Czechia
Na Homolce Hospital
Prague, Czechia, 15030
Germany
Universitätsmedizin Göttingen
Hanover, Göttingen, Germany, 37075
Universitätsklinikum Essen
Essen, Nordrhein-Westfalen, Germany, 45122
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen, Germany, 29549
Charité Berlin - Campus Benjamin Franklin
Berlin, Germany, 12203
Charité Campus-Virchow-Klinikum
Berlin, Germany, 13353
ASKLEPIOS Klinik St. Georg
Hamburg, Germany, 20099
UKE - Universitäres Herzzentrum GmbH
Hamburg, Germany, 20246
Universitätsmedizin Mannheim
Mannheim, Germany, 68167
Klinikum der Univ. München - Grosshadern
München, Germany, 81377
Sponsors and Collaborators
Impulse Dynamics
Investigators
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Study Director: Daniel Burkhoff, MD, PhD Impulse Dynamics

Additional Information:
Publications:

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Responsible Party: Impulse Dynamics
ClinicalTrials.gov Identifier: NCT01381172     History of Changes
Other Study ID Numbers: CP OPT2009-009
G030099 ( Other Identifier: FDA )
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

Keywords provided by Impulse Dynamics:
Heart Failure
Congestive Heart Failure
Chronic heart disease
Cardiac contractility modulation
CCM
CHF

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases