NCT01124136

Neurostimulation of Spinal Nerves That Affect the Heart

Evaluation of the Effect of Neurostimulation in Patients With Symptomatic Heart Failure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Jerry Estep, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Protocol Summary Title EVALUATION OF THE SAFETY OF NEUROSTIMULATION IN PATIENTS WITH SYMPTOMATIC HEART FAILURE FEASIBILTIY STUDY Description A feasibility trial of the use of neurostimulation in chronic advanced refractory heart failure. Objective To determine the safety of neurostimulation in patients with chronic advanced refractory heart failure and to generate initial observations with regards to its potential effect on ventricular function and quality of life. Design The trial will be a randomized double blind crossover feasibility trial with 2 week and 1,2,3,4,5,6,7 month clinical follow-up. After device implantation, patients enrolled in the trial will have been randomly assigned to have device programmed to deliver impulses, active, or to have the device programmed not to deliver impulses, inactive, for 3 months. After the 3 month initial phase, the devices will be inactivated and a 4 week washout period will convene. At the end of washout period, patients that were inactive during initial phase will crossover to active and similarly patients that were active during initial phase will crossover to inactive. Patient Population Patients with non-ischemic or ischemic cardiomyopathy with a length of illness of at least 6 months who have met the inclusion and exclusion criteria. Enrollment Enrollment of a total of 10 intent-to-treat patients Investigational Sites Up to 2 investigational sites in the US Data Collection Data collection will be obtained in three categories: markers of cardiovascular safety, markers of device-device interactions and markers of efficacy.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-05-01
• Primary completion: 2018-10-01
• Completion: 2018-11-01
• First posted: 2010-05-14
• Last updated: 2018-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study