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

NCT03339310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-14

No results posted yet for this study

Summary

This is a multicenter, prospective, single-arm study of the Optimizer Smart System with 2-leads

Conditions

  • Heart Failure
  • Congestive Heart Failure
  • Chronic Heart Disease
  • CHF

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.

Sponsors & Collaborators

  • Impulse Dynamics

    lead INDUSTRY

Principal Investigators

  • David D. Gutterman, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2019-10-30
Completion
2019-10-30
FDA Device
Yes

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03339310 on ClinicalTrials.gov