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Neurostimulation of Spinal Nerves That Affect the Heart

NCT01124136 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-01-12

No results posted yet for this study

Summary

The purpose of this study is to study the use of neurostimulation in chronic advanced refractory heart failure.

The study is determine if it is safe to use neurostimulation in patients with chronic advanced refractory heart failure and to also determine initial observations with regards to its potential effect on heart function and quality of life. The investigators hypothesis is that this study will show both safe and positive effect of neurostimulation on heart failure patients.

Conditions

Interventions

DEVICE

Neurostimulation + Medication Management (Standard of Care)

In addition to medication management, adding investigational implanted neurostimulator to heart

DRUG

Standard of Care (Control)

Standard of Care Therapy consists of medication management only to support heart for rhythm, anticoagulation, and rate, and comorbid symptoms, i.e. diuretics, lipid lowering.

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Jerry Estep, MD

    lead OTHER

Principal Investigators

  • Jerry Estep, MD · Methodist Hospital DeBakey Heart & Vascular Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2018-10-31
Completion
2018-11-30
FDA Device
Yes

Countries

  • United States

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 NCT01124136 on ClinicalTrials.gov