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The purpose of this research study is to examine the effect of cardiac denervation surgery, otherwise known as left cervicosympathectomy, on life threatening abnormal heart rhythms that can lead to sudden cardiac death.
Subjects will be asked to participate in this research trial if they have an indication and have been referred for ICD placement or have recently had an ICD placed, are at risk for abnormal heart rhythms, called ventricular tachycardias, and have already experienced at least one episode of ventricular tachycardia or fibrillation. The goal of this study is to determine whether left cervicosympathectomy can prevent these abnormal heart rhythms from occurring and therefore, prevent, ICD shocks, which are not only painful, but have been shown to reduce quality of life and/or lead to depression, particularly in the period immediately after the shock.
The purpose of this research study is to examine the effect of a procedure called left cervicothoracic sympathectomy which involves removal of part of the cervical stellate ganglia and thoracic ganglia of level 2 to 4. These ganglia house the left sided nerves that feed the heart and have been implicated in the occurrence of fast abnormal rhythms that cause defibrillator shocks and sudden death. Stimulation of these nerves has been shown to increase the incidence of sudden death and fast abnormal heart rhythms that lead to internal defibrillator shocks called ventricular tachycardia/ventricular fibrillation. Removal of the ganglia of these nerves in animal and human studies has been shown to decrease the incidence of life threatening abnormal rhythms and sudden death. The purpose of this study is to examine whether this procedure along with an internal defibrillator and current maximum medical therapy can reduce the incidence of these life threatening abnormal rhythms as compared to an internal defibrillator and medical therapy alone.
We are inviting patients to participate in this clinical trial whose personal physician has recommended that they have a internal defibrillator placed because they have already experienced one of these life threatening arrhythmias or because you already have an internal defibrillator that has shocked you at least once for the presence of these fast abnormal rhythms. You maybe randomized to receive the procedure and an internal defibrillator (if you don't have one already) plus maximum medical therapy or to receive the defibrillator and medical therapy. The procedure involves removal of part of the left sided ganglia of the nerves that feed the heart. This procedure takes less than 45 minutes and can be performed endoscopically.
We are asking 216 individuals (approximate age range 18-80 years) who are scheduled to have an internal defibrillator placed at UCLA and CARE center (though other centers are currently under consideration) to participate in this research trial but only half these individual will be randomized under the left cervicothoracic sympathectomy.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Sudden Cardiac Death
Left cervicothoracic sympathectomy, ICD and medical therapy only
Not yet recruiting
University of California, Los Angeles
Published on BioPortfolio: 2014-07-23T21:11:48-0400
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