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



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:January 2011
End Date:April 2019

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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

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.

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.

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.
We found this trial at
33
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Joseph Akar, MD
Phone: 203-737-1330
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Robert Kociol, MD
Phone: 617-632-8956
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Victor See, MD
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Brighton, Massachusetts 02135
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Cincinnati, Ohio 45219
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Columbus, Ohio 43210
Principal Investigator: Rami Kahwash, MD
Phone: 614-247-6797
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4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
Principal Investigator: Phi Wiegn, MD
Phone: 214-857-1535
Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
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Detroit, Michigan
Principal Investigator: Randy Lieberman, MD
Phone: 313-745-9924
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Falls Church, Virginia 22042
Principal Investigator: Marc Wish, MD
Phone: 703-776-6007
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Germantown, Tennessee 38138
Principal Investigator: Frank McGrew, MD
Phone: 901-282-4181
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Glendale, Arizona 85306
Principal Investigator: Andy Tran, MD
Phone: 602-652-8761
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Vladimir Cotarlan-Nistor, MD
Phone: 319-353-7953
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Lexington, Kentucky 40503
Principal Investigator: Gery Tomassoni, MD
Phone: 859-260-6429
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Lincoln, Nebraska 68526
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Lincoln, Nebraska 69506
Principal Investigator: Steven Krueger, MD
Phone: 402-483-3294
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Mesa, Arizona 85206
Principal Investigator: Andrew Kaplan, MD
Phone: 480-641-5400
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Mesa, Arizona 85206
Principal Investigator: Rodrigo Chan, MD
Phone: 480-773-2220
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Milwaukee, Wisconsin 53215
Principal Investigator: Imran Niazi, MD
Phone: 262-249-5432
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Naperville, Illinois 60566
Principal Investigator: Maria Rosa Costanzo, MD
Phone: 630-785-2241
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New Orleans, Louisiana 70121
Principal Investigator: Freddy Abi-Samra, MD
Phone: 504-842-8476
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New York, New York 10029
Principal Investigator: Marc Miller, MD
Phone: 212-824-8931
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Newark, New Jersey 07107
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Newport Beach, California 92658
Principal Investigator: Jay Lee, MD
Phone: 714-564-3327
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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Phoenix, Arizona 53226
Principal Investigator: Vijay Swarup, MD
Phone: 602-456-2342
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Prague, 15630
Principal Investigator: Petr Neuzil, Prof
Phone: +420 257273301
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Sayre, Pennsylvania 18840
Principal Investigator: Pramod Deshmukh, MD
Phone: 570-887-6071
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101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Principal Investigator: David Rodak, MD
Phone: 864-560-1042
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Takoma Park, Maryland 20912
Principal Investigator: Sean Beinart, MD
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Tucson, Arizona 85724
Principal Investigator: Peter Ott, MD
Phone: 520-626-5431
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Tucson, Arizona 85718
Principal Investigator: Darren Peress, MD
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Tyler, Texas 75701
Principal Investigator: Stan Weiner, MD
Phone: 903-510-8846
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