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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Impulse Dynamics
ClinicalTrials.gov Identifier:
NCT00112125
First received: May 27, 2005
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Heart Failure, Congestive
Device: OPTIMIZER System
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Impulse Dynamics:

Primary Outcome Measures:
  • Change in exercise tolerance quantified by change in ventilatory threshold measured on cardiopulmonary exercise test [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 418
Study Start Date: February 2005
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Optimizer System + Optimal medical treatment
Optimizer System implanted and cardiac contractility modulation therapy activated.
Device: OPTIMIZER System
No Intervention: Optimal medical treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112125

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Impulse Dynamics
ClinicalTrials.gov Identifier: NCT00112125     History of Changes
Other Study ID Numbers: #IDPT 2003-07-C, FIX-HF-5
Study First Received: May 27, 2005
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Impulse Dynamics:
cardiac contractility modulation
heart failure
cardiopulmonary exercise test
chronic heart disease

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014