Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 23, 2017

Primary Completion Date

October 30, 2019

Study Completion Date

October 30, 2019

Conditions
Heart FailureCongestive Heart FailureChronic Heart DiseaseCHF
Interventions
DEVICE

Optimizer Smart System with 2-leads

The Optimizer Smart System with 2-leads delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Implanted subjects receive five non-contiguous one-hour periods of CCM signals per day.

Trial Locations (10)

40503

Baptist Health Systems, Lexington

44789

University Hospital gGmbH Bergmannsheil, Bochum

70121

Ochsner Clinic Foundation, New Orleans

75216

Dallas VA Hospital, Dallas

75701

CHRISTUS Trinity Mother Frances, Tyler

85032

Cardiovascular Consultants, Phoenix

85206

Chan Heart Rhythm Institute, Mesa

Southwest Cardiology Associates, Mesa

85251

Arizona Arrhythmia Consultants, Scottsdale

85712

Pima Heart Physicians, PC, Tucson

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Impulse Dynamics

INDUSTRY

NCT03339310 - Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System | Biotech Hunter | Biotech Hunter