Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

NATerminatedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

July 1, 2017

Primary Completion Date

December 16, 2019

Study Completion Date

December 16, 2019

Conditions
Heart FailureCongestive Heart FailureChronic Heart DiseaseCHF
Interventions
DEVICE

Optimizer Smart System

The Optimizer Smart 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.

Trial Locations (17)

18840

Guthrie Medical Group at Robert Packer Hospital, Sayre

19047

St. Mary Research Institute, Langhorne

Jefferson Heart Institute, Philadelphia

19104

Hospital of the University of Pennsylvania, Philadelphia

Penn Presbyterian Medical Center, Philadelphia

40503

Baptist Health Lexington, Lexington

40536

University of Kentucky, Lexington

43210

Ohio State University Wexner Medical Center, Columbus

70121

Ochsner Clinic Foundation, New Orleans

75390

UT Southwestern Medical Center, Dallas

75701

CHRISTUS Trinity Mother Frances Health System, Tyler

85027

Cardiovascular Consultants, Phoenix

85206

Chan Heart Rhythm Institute, Mesa

Southwest Cardiology Associates, Mesa

85251

Arizona Arrhythmia Consultants, Scottsdale

85745

Pima Heart, Tucson

08103

Cooper University Hospital, Camden

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Impulse Dynamics

INDUSTRY

NCT03102437 - Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System | Biotech Hunter | Biotech Hunter