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Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure

NCT01112579 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2015-10-29

Study results available
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Summary

The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.

Conditions

Interventions

DEVICE

Medtronic PrimeADVANCED Neurostimulator

Heart failure therapy

DEVICE

Medtronic PrimeADVANCED Neurostimulator

Medical management

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Douglas P Zipes, M.D. · Krannert Institute of Cardiology

  • Heinz Theres, M.D. · Charite Universitatsmedizin Berlin - Campus Charite Mitte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-01-31
Completion
2015-04-30

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Italy
  • Netherlands
  • South Africa
  • Sweden

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 NCT01112579 on ClinicalTrials.gov