Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With NYHA Class III Heart Failure Symptoms: FIX-HF-5B

This study is currently recruiting participants.
Verified September 2012 by Impulse Dynamics
Sponsor:
Information provided by (Responsible Party):
Impulse Dynamics
ClinicalTrials.gov Identifier:
NCT01381172
First received: June 22, 2011
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

The purpose of the FIX-HF-5B Study is to determine whether the OPTIMIZER™ System is effective in improving the way people with moderate to severe heart failure feel.


Condition Intervention
NYHA Class III Heart Failure
Device: CCM therapy
Other: No intervention: Optimal medical therapy

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 in Subjects With Heart Failure With Ejection Fraction Between 25% and 45% and NYHA Class III Symptoms: FIX-HF-5B

Resource links provided by NLM:


Further study details as provided by Impulse Dynamics:

Primary Outcome Measures:
  • improvement in exercise tolerance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    ventilatory threshold (VT) measured on cardiopulmonary exercise test


Secondary Outcome Measures:
  • peak VO2 and MLWHFQ [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    peak VO2 determined on CPX testing and quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ)


Estimated Enrollment: 230
Study Start Date: January 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Device: CCM therapy
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.
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.

Detailed Description:

The Impulse Dynamics FIX-HF-5B 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 heart failure and an ejection fraction 25-45%. The study will involve the recruitment of 230 subjects at a total of up to 30 sites nationwide.

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 6 months 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.

The primary efficacy assessment consists of a change in exercise tolerance measured by cardiopulmonary exercise testing at baseline and 6 months. Safety is assessed by OPTIMIZER device- or OPTIMIZER procedure-related complications through 6 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 greater than or equal to 25% and less than or equal to 45% by echocardiography determined by the echocardiography core laboratory.
  • 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 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 b-blocker. Stable is defined as no more than a 100% increase or 50% decrease in dose.
  • Subjects who, in the opinion of the Principal Investigator (based on the current guidelines for clinical practice1), 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 O2/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 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 PVCs per 24 hours on baseline Holter monitoring.
  • Subjects having a PR interval greater than 275 ms.
  • Subjects who have chronic (permanent or persistent) atrial fibrillation or 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, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to perform baseline stress testing.
  • 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.
  • 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.
  • Subjects who were previously randomized in an OPTIMIZER System study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381172

Contacts
Contact: Angela Stagg 845-359-2389 ext 572 angelas@impulse-dynamics.com

Locations
United States, Louisiana
Ochsner Clinic Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Cris Wright    504-842-0256    chrwright@ochsner.org   
Contact: Melanie Lunn    504-842-2372    MLunn@ochsner.org   
Principal Investigator: Freddy Abi-Samra, MD         
United States, Nebraska
Bryan LGH Recruiting
Lincoln, Nebraska, United States, 69506
Contact: June Christy, RN    402-483-3372    june@bhi-1.com   
Principal Investigator: Steve Krueger, MD         
United States, New Jersey
UMDNJ Recruiting
Newark, New Jersey, United States, 07103
Contact: Ryann L Mattessich, RN    973-972-4708    Casaterl@umdnj.edu   
Principal Investigator: Marc Klapholz, MD         
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Debra A Cannon, RN    614-292-6789    Debra.Cannon@osumc.edu   
Principal Investigator: Rami Kahwash, MD         
United States, Texas
Lone Star Heart Center Active, not recruiting
Amarillo, Texas, United States, 79106
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Anagha Phadke, Ph.D.    214-857-2280    Anagha.Phadke@va.gov   
Principal Investigator: Owen Obel, MD         
Trinity Clinic Active, not recruiting
Tyler, Texas, United States, 75701
United States, Wisconsin
Aurora Health Care Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Rebecca L Dahme, RN       rebecca.dahme@aurora.org   
Principal Investigator: Imran K Niazi, MD         
Sponsors and Collaborators
Impulse Dynamics
Investigators
Study Director: Daniel Burkhoff, MD, PhD Impulse Dynamics
  More Information

Additional Information:
Publications:
Responsible Party: Impulse Dynamics
ClinicalTrials.gov Identifier: NCT01381172     History of Changes
Other Study ID Numbers: CP OPT2009-009
Study First Received: June 22, 2011
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014