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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Impulse Dynamics
Sponsor:
Information provided by (Responsible Party):
Impulse Dynamics
ClinicalTrials.gov Identifier:
NCT01381172
First received: June 22, 2011
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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 Intervention
NYHA Class III Heart Failure
NYHA Class IV Heart Failure
Device: Optimizer System
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 Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%: FIX-HF-5C

Resource links provided by NLM:


Further study details as provided by Impulse Dynamics:

Primary Outcome Measures:
  • Improvement in exercise tolerance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Exercise tolerance quantified by peak VO2 measured with cardiopulmonary exercise stress testing (CPX)


Secondary Outcome Measures:
  • MLWHFQ [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Peak VO2 with change in respiratory exchange ratio (RER) included as a covariate.

  • NYHA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Peak VO2 in an analysis that only includes tests with a peak RER of ≥1.05.


Other Outcome Measures:
  • 6 Minute Hall Walk [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Distance walked in 6 minutes

  • VE/VCO2 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    VE/VCO2 as measured during cardiopulmonary stress testing.


Estimated Enrollment: 230
Study Start Date: January 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (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: 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.

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 230 subjects at a total of up to 40 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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. In Europe, ivabradine may also be considered in subjects with a heart rate >70bpm. 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 or aortic valves.
  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.
  17. Subjects who were previously randomized in an OPTIMIZER System study.
  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: NCT01381172

Contacts
Contact: Angela Stagg 845-359-2389 ext 206 angelas@impulse-dynamics.com

Locations
United States, Florida
Florida Hospital Not yet recruiting
Orlando, Florida, United States, 32803
Contact: Carol Stastny, RN    407-303-5600 ext 1103439    Carol.Stastny@FLHOSP.ORG   
Principal Investigator: George Monir, MD         
Sub-Investigator: Nirav Raval, MD         
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Melody Muir, RN    859-260-6429    melody.muir@bhsi.com   
Contact: Melissa Shepherd, RN       melissa.shepherd@bhsi.com   
Principal Investigator: Gery F. Tomassoni, MD         
United States, Louisiana
Ochsner Clinic Active, not recruiting
New Orleans, Louisiana, United States, 70121
United States, Nebraska
Bryan LGH Active, not recruiting
Lincoln, Nebraska, United States, 69506
United States, New Jersey
UMDNJ Active, not recruiting
Newark, New Jersey, United States, 07103
United States, Ohio
The Lindner Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Tessa Messinger, RN    513-585-1698    Tessa.Messinger@thechristhospital.com   
Principal Investigator: Eugene S. Chung, MD         
The Ohio State University Medical Center Active, not recruiting
Columbus, Ohio, United States, 43210
United States, South Carolina
Spartanburg Regional Medical Center Not yet recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Darla Howard, RN    864-560-1042    dhoward@gibbscc.org   
Principal Investigator: David Rodak, MD         
United States, Texas
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
Contact: Disha Kohli    214-857-2280    Disha.Kohli@va.gov   
Principal Investigator: Owen Obel, MD         
Trinity Clinic Recruiting
Tyler, Texas, United States, 75701
Contact: Carol Cushman    903-510-8846    Carol.Cushman@tmfhc.org   
Principal Investigator: Stanislav Weiner, MD         
United States, Virginia
Inova Heart & Vascular Institute Active, not recruiting
Falls Church, Virginia, United States, 22042
United States, Wisconsin
Aurora Health Care Active, not recruiting
Milwaukee, Wisconsin, United States, 53215
Czech Republic
Na Homolce Hospital Not yet recruiting
Prague, Czech Republic, 15030
Contact: Liz Coling    +420 257272391    Liz.coling@homolka.cz   
Contact: Štěpán Královec    +420 777671069    stepan.kralovec@gmail.com   
Principal Investigator: Petr Neuzil, Prof         
Germany
Herz- und Gefässzentrum Bad Bevensen Not yet recruiting
Bad Bevensen, Germany, 29549
Contact: Carmen Latzko    +49 (0) 5821 826693    c.latzko@hgz-bb.de   
Principal Investigator: Bjoern Andrew Remppis, Dr.         
ASKLEPIOS Klinik St. Georg Not yet recruiting
Hamburg, Germany, 20099
Contact: Dagmar Pilz    +49 (0)40 18 18 85 3078    da.pilz@asklepios.com   
Contact: Cornelia Wolf    +40/18 18-85 3069    co.wolf@asklepios.com   
Principal Investigator: Karl-Heinz Kuck, Prof.         
UKE - Universitäres Herzzentrum GmbH Not yet recruiting
Hamburg, Germany, 20246
Contact: Katrin Fuerst    +40/7410-59471    k.fuerst@uke.de   
Universitätsmedizin Mannheim Not yet recruiting
Mannheim, Germany, 68167
Contact: Susanne Röger, Dr       susanne.roeger@umm.de   
Principal Investigator: Martin Borggrefe, Prof.         
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, G030099
Study First Received: June 22, 2011
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014