Advertisement

Topics

Cardiac Denervation Surgery for Prevention of Ventricular Tachycardia

2014-07-23 21:11:48 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Sudden Cardiac Death

Intervention

Left cervicothoracic sympathectomy, ICD and medical therapy only

Location

UCLA
Los Angeles
California
United States
90065

Status

Not yet recruiting

Source

University of California, Los Angeles

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:48-0400

Clinical Trials [1940 Associated Clinical Trials listed on BioPortfolio]

Thoracoscopic Sympathectomy for Blushing

To determine outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing and investigate if there are any significant differen...

Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study

A randomized controlled trial to test the potential safety and efficacy of LCSD in patients with heart failure due to non-ischemic and ischemic cardiomyopathy at the University of Cape Tow...

Cardiac AResT And GENEtic

Sudden death is a major problem in industrially developed countries. Despite a decline in ischemic heart disease mortality and the progress has been made in resuscitation, treatment of sud...

Quantitive LGE Mass in Prediction of SCD in NICM Patients With Severe Cardiac Dysfunction

The purpose of this study is to establish a quantitative LGE mass based scoring system (including LGE mass on cardiac magnetic resonance , clinical features, specific medical histories, et...

Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death

This study evaluates the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients. This is a single arm prospec...

PubMed Articles [21184 Associated PubMed Articles listed on BioPortfolio]

Can We Use the Intrinsic Left Ventricular Delay (QLV) to Optimize the Pacing Configuration for Cardiac Resynchronization Therapy With a Quadripolar Left Ventricular Lead?

Previous studies indicated the importance of the intrinsic left ventricular (LV) electric delay (QLV) for optimal benefit to cardiac resynchronization therapy. We investigated the use of QLV for achie...

The nightmare ECG of a spontaneously aborted sudden cardiac death.

We present the case of a spontaneously aborted sudden cardiac death related to an high-rate ventricular tachycardia in an healthy man with bileaflet mitral valve prolapse. An effective treatment of th...

Outcomes of Cardiac Screening in Adolescent Soccer Players.

Background Reports on the incidence and causes of sudden cardiac death among young athletes have relied largely on estimated rates of participation and varied methods of reporting. We sought to invest...

Biomarkers as predictors of sudden cardiac death in coronary artery disease patients with preserved left ventricular function (ARTEMIS study).

Biomarkers have shown promising results in risk assessment of cardiovascular events. Their role in predicting the risk of sudden cardiac death (SCD) is not well established. We tested the performance ...

The epidemiology of sudden cardiac arrest in prehospital care in the area of the silesian voivodeship.

Introduction: Sudden cardiac arrest (SCA) is a serious medical and social issue. The incidence of SCA varies depending on the location and the circumstances. The aim: A retrospective analysis of non-h...

Medical and Biotech [MESH] Definitions

Inflammatory processes of the muscular walls of the heart (MYOCARDIUM) which result in injury to the cardiac muscle cells (MYOCYTES, CARDIAC). Manifestations range from subclinical to sudden death (DEATH, SUDDEN). Myocarditis in association with cardiac dysfunction is classified as inflammatory CARDIOMYOPATHY usually caused by INFECTION, autoimmune diseases, or responses to toxic substances. Myocarditis is also a common cause of DILATED CARDIOMYOPATHY and other cardiomyopathies.

Unexpected rapid natural death due to cardiovascular collapse within one hour of initial symptoms. It is usually caused by the worsening of existing heart diseases. The sudden onset of symptoms, such as CHEST PAIN and CARDIAC ARRHYTHMIAS, particularly VENTRICULAR TACHYCARDIA, can lead to the loss of consciousness and cardiac arrest followed by biological death. (from Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine, 7th ed., 2005)

Sympathectomy using chemicals (e.g., 6-hydroxydopamine or guanethidine) which selectively and reversibly destroy adrenergic nerve endings while leaving cholinergic nerve endings intact.

The research and development of ELECTRICAL EQUIPMENT AND SUPPLIES for such medical applications as diagnosis, therapy, research, anesthesia control, cardiac control, and surgery. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)

A condition caused by underdevelopment of the whole left half of the heart. It is characterized by hypoplasia of the left cardiac chambers (HEART ATRIUM; HEART VENTRICLE), the AORTA, the AORTIC VALVE, and the MITRAL VALVE. Severe symptoms appear in early infancy when DUCTUS ARTERIOSUS closes.

More From BioPortfolio on "Cardiac Denervation Surgery for Prevention of Ventricular Tachycardia"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Cardiology
Cardiology is a specialty of internal medicine.  Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...

Cardiovascular disease (CVD)
Acute Coronary Syndromes (ACS) Blood Cardiovascular Dialysis Hypertension Stent Stroke Vascular Cardiovascular disease (CVD) includes all the diseases of the heart and circulation including coronary heart disease (angina...


Searches Linking to this Trial