Chronic Heart Failure Clinical Trial
Official title:
Evaluation of the Effect of Neurostimulation in Patients With Symptomatic Heart Failure
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.
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.
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