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

Status: Completed
Location: See all (41) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
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• Subjects who are 18 years of age or older

• 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.

• Condition

• 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 subject is intolerant) and are in New York Heart Association functional Class III and IV at the time of enrollment.

• 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.

• 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.

• Subjects who are willing and able to return for all follow-up visits.

Locations
United States
Arizona
Cardiovascular Consultants
Glendale
Cardiovascular Associates of Mesa
Mesa
Chan Heart Rhythm Institute
Mesa
Arizona Heart & Rhythm Center
Phoenix
Pima Heart
Tucson
University of Arizona Sarver Heart Center
Tucson
California
Hoag Memorial Hospital Presbyterian
Newport Beach
Connecticut
Yale - New Haven Hospital
New Haven
Florida
Florida Hospital
Orlando
Florida Hospital - Pepin Heart Institute
Tampa
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Illinois
Advocate Medical Group - Midwest Heart Foundation
Naperville
Kentucky
Baptist Health Lexington
Lexington
Louisiana
Ochsner Clinic
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
Boston
St. Elizabeth's Medical Center
Brighton
Maryland
University of Maryland
Baltimore
Washington Adventist Hospital
Takoma Park
Michigan
Detroit Medical Center - Cardiovascular Institute
Detroit
Nebraska
Bryan Heart LGH
Lincoln
Nebraska Heart Institute
Lincoln
New Jersey
UMDNJ
Newark
New York
Mt. Sinai Medical Center
New York
Ohio
The Lindner Center
Cincinnati
The Ohio State University Medical Center
Columbus
Pennsylvania
Guthrie Medical Group
Sayre
South Carolina
Spartanburg Regional Medical Center
Spartanburg
Tennessee
Stern Cardiovascular Foundation
Germantown
Texas
Dallas VA Medical Center
Dallas
Trinity Clinic
Tyler
Virginia
Inova Heart & Vascular Institute
Falls Church
Wisconsin
Aurora Health Care
Milwaukee
Other Locations
Germany
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen
Charité Berlin - Campus Benjamin Franklin
Berlin
Charité Campus-Virchow-Klinikum
Berlin
Universitätsklinikum Essen
Essen
ASKLEPIOS Klinik St. Georg
Hamburg
UKE - Universitäres Herzzentrum GmbH
Hamburg
Universitätsmedizin Göttingen
Hanover
Universitätsmedizin Mannheim
Mannheim
Klinikum der Univ. München - Grosshadern
München
Time Frame
Start Date: January 2011
Completion Date: March 19, 2019
Participants
Target number of participants: 160
Treatments
Experimental: Treatment
The treatment group receives the OPTIMIZER System implant and continues with optimal heart failure medical therapy.
Other: Control
The Control group will not receive the OPTIMIZER System and will continue with optimal heart failure medical therapy.
Related Therapeutic Areas
Sponsors
Leads: Impulse Dynamics

This content was sourced from clinicaltrials.gov

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