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Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5

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. Identifier: NCT00112125
Recruitment Status : Completed
First Posted : May 30, 2005
Last Update Posted : January 31, 2020
Information provided by (Responsible Party):
Impulse Dynamics

Brief Summary:
The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Device: OPTIMIZER System Not Applicable

Detailed Description:

IMPULSE Dynamics' FIX HF 5 US Study is a prospective, multi-center, 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/IV heart failure. The study will involve the recruitment of approximately 420 subjects at a total of up to 50 sites nationwide.

Those subjects who fulfill all inclusion and exclusion criteria based upon baseline test results will be randomized to receive the OPTIMIZER™ System or to a control group. All subjects randomized will be followed for 1 year and shall receive the same study related assessments throughout the course of the study. In addition, all subjects will continue to receive optimal medical therapy for the treatment of their heart failure.

The primary efficacy assessment consists of a change in exercise tolerance measured by cardiopulmonary exercise testing at baseline and 6 months. Safety variables, such as the rate and cause of hospitalizations or death, shall be collected in both groups and shall be compared at 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 428 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 With Active Fixation Leads in Subjects With Heart Failure Resulting From Systolic Dysfunction: FIX-HF-5
Actual Study Start Date : February 2005
Actual Primary Completion Date : March 19, 2019
Actual Study Completion Date : March 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Optimizer System + Optimal medical treatment
Optimizer System implanted and cardiac contractility modulation therapy activated.
Device: OPTIMIZER System
No Intervention: Optimal medical treatment

Primary Outcome Measures :
  1. Change in exercise tolerance quantified by change in ventilatory threshold measured on cardiopulmonary exercise test [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Efficacy: Improvement in New York Heart Association (NYHA) Class; improvement in quality of life; change in left ventricular ejection fraction; change in left ventricular end diastolic dimension. [ Time Frame: 6 months ]
  2. Safety: all-cause mortality; cardiac mortality; the rate of all-cause hospitalizations; the rate of cardiac-related hospitalizations; overall incidence and severity of adverse events [ Time Frame: 1 year ]

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

Inclusion Criteria:

  • Subjects who are 18 years of age or older
  • Subjects who are either male or female
  • Subjects who have a baseline ejection fraction of 35% or less by echocardiography.
  • 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 patient is intolerant) and are in New York Heart Association functional Class III or IV at the time of enrollment.
  • Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure, consisting 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.
  • Subjects who, in the opinion of the Principle Investigator (based on the current guidelines for clinical practice), have a clinical indication for an implanted cardiac defibrillator (ICD) 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.
  • Subjects who are willing and able to return for all follow-up visits.

Exclusion Criteria:

  • Subjects whose baseline VO2,max is <9 ml 02/min/kg.
  • Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
  • 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 electrocardiography (ECG) changes during exercise testing performed during baseline evaluation.
  • Subjects who have been hospitalized for heart failure which required the use of inotropic support within 30 days of enrollment.
  • Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 premature ventricular complexes (PVCs) per 24 hours on baseline Holter monitoring.
  • Subjects who have chronic atrial fibrillation or chronic atrial flutter or those cardioverted within 30 days of enrollment.
  • Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, chronic obstructive pulmonary disease [COPD], peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to participate in a 6-minute walk or a cardiopulmonary stress test.
  • Subjects who are scheduled for a coronary artery bypass graft (CABG) or a percutaneous transluminal coronary angioplasty (PTCA) procedure, or who have undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.
  • Subjects who have a biventricular pacing system or who have an accepted indication for such a device.
  • Subjects who have had a myocardial infarction within 90 days of enrollment.
  • Subjects who have mechanical tricuspid or aortic valves.
  • Subjects who have a prior heart transplant.
  • Subjects who are participating in another experimental protocol.
  • 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 identifier (NCT number): NCT00112125

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United States, New York
Impulse Dynamics
Orangeburg, New York, United States, 10962
Sponsors and Collaborators
Impulse Dynamics
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Study Director: Dan Burkhoff, M.D, Ph.D. Impulse Dynamics


Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Impulse Dynamics Identifier: NCT00112125    
Other Study ID Numbers: #IDPT 2003-07-C
First Posted: May 30, 2005    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Keywords provided by Impulse Dynamics:
cardiac contractility modulation
heart failure
cardiopulmonary exercise test
chronic heart disease
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases