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

NACompletedINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

March 19, 2019

Study Completion Date

March 19, 2019

Conditions
NYHA Class III Heart FailureNYHA Class IV Heart Failure
Interventions
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

No intervention: Optimal medical therapy

The control group receives optimal medical therapy only.

Trial Locations (42)

10029

Mt. Sinai Medical Center, New York

12203

Charité Berlin - Campus Benjamin Franklin, Berlin

13353

Charité Campus-Virchow-Klinikum, Berlin

15030

Na Homolce Hospital, Prague

18840

Guthrie Medical Group, Sayre

20099

ASKLEPIOS Klinik St. Georg, Hamburg

20246

UKE - Universitäres Herzzentrum GmbH, Hamburg

20912

Washington Adventist Hospital, Takoma Park

21201

University of Maryland, Baltimore

22042

Inova Heart & Vascular Institute, Falls Church

29303

Spartanburg Regional Medical Center, Spartanburg

29549

Herz- und Gefässzentrum Bad Bevensen, Bad Bevensen

32803

Florida Hospital, Orlando

33613

Florida Hospital - Pepin Heart Institute, Tampa

37075

Universitätsmedizin Göttingen, Hanover

38138

Stern Cardiovascular Foundation, Germantown

40503

Baptist Health Lexington, Lexington

43210

The Ohio State University Medical Center, Columbus

45122

Universitätsklinikum Essen, Essen

45219

The Lindner Center, Cincinnati

48201

Detroit Medical Center - Cardiovascular Institute, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

53215

Aurora Health Care, Milwaukee

60540

Advocate Medical Group - Midwest Heart Foundation, Naperville

68167

Universitätsmedizin Mannheim, Mannheim

68526

Nebraska Heart Institute, Lincoln

69506

Bryan Heart LGH, Lincoln

70121

Ochsner Clinic, New Orleans

75216

Dallas VA Medical Center, Dallas

75701

Trinity Clinic, Tyler

81377

Klinikum der Univ. München - Grosshadern, München

85013

Arizona Heart & Rhythm Center, Phoenix

85206

Cardiovascular Associates of Mesa, Mesa

Chan Heart Rhythm Institute, Mesa

85306

Cardiovascular Consultants, Glendale

85712

Pima Heart, Tucson

85724

University of Arizona Sarver Heart Center, Tucson

92663

Hoag Memorial Hospital Presbyterian, Newport Beach

06519

Yale - New Haven Hospital, New Haven

02215

Beth Israel Deaconess Medical Center, Boston

02135

St. Elizabeth's Medical Center, Brighton

07103

UMDNJ, Newark

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Impulse Dynamics

INDUSTRY

NCT01381172 - Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C | Biotech Hunter | Biotech Hunter