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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

Tracking Information
First Submitted Date  ICMJE June 22, 2011
First Posted Date  ICMJE June 27, 2011
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE January 2011
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2014)
Improvement in exercise tolerance [ Time Frame: 24 weeks ]
Exercise tolerance quantified by peak VO2 measured with cardiopulmonary exercise stress testing (CPX)
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
  • Primary Efficacy Endpoint [ Time Frame: 6 months ]
    Number of participants who respond to therpay (Optimal Medical Therpay vs. Optimizer) as a measure of efficacy.
  • Primary Safety Endpoint [ Time Frame: 6 months ]
    Number of subjects (in the treatment group) not experiencing an Optimizer device or Optimizer procedure related complication or all-cause death through 6 months.
Change History Complete list of historical versions of study NCT01381172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2014)
  • MLWHFQ [ Time Frame: 24 weeks ]
    Quality of life, as assessed by the Minnesota Living with Heart Failure (MLWHF) Questionnaire
  • Peak VO2 with respiratory exchange ratio (RER) [ Time Frame: 24 weeks ]
    Peak VO2 with change in respiratory exchange ratio (RER) included as a covariate.
  • NYHA [ Time Frame: 24 weeks ]
    Heart failure class, as assessed by the New York Heart Association (NYHA) classification.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 21, 2014)
  • 6 Minute Hall Walk [ Time Frame: 24 weeks ]
    Distance walked in 6 minutes
  • VE/VCO2 [ Time Frame: 24 weeks ]
    VE/VCO2 as measured during cardiopulmonary stress testing.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • NYHA Class III Heart Failure
  • NYHA Class IV Heart Failure
Intervention  ICMJE
  • 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
  • Other: No intervention: Optimal medical therapy
    The control group receives optimal medical therapy only.
Study Arms  ICMJE
  • Experimental: Treatment
    The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
    Intervention: Device: Optimizer System
  • Control
    The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
    Intervention: Other: No intervention: Optimal medical therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 29, 2016)
160
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2011)
230
Estimated Study Completion Date  ICMJE April 2019
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Germany,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01381172
Other Study ID Numbers  ICMJE CP OPT2009-009
G030099 ( Other Identifier: FDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Impulse Dynamics
Study Sponsor  ICMJE Impulse Dynamics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daniel Burkhoff, MD, PhD Impulse Dynamics
PRS Account Impulse Dynamics
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP