Clinical Trial: Is Left Stellate Ganglionectomy Beneficial to Patients With Life Threatening Ventricular Arrhythmias
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Does Left Cardiac Sympathectomy Stellate Ganglionectomy Confer an Added Benefit Over Optimal Medical Therapy in the Reduction of Therapy Delivered From an Implanted Cardioverter Defibrillator in Patie
Brief Summary: The purpose of this study is to determine whether the incidence of recurrent life threatening ventricular arrhythmias in patients with an implanted cardiac defibrillator (ICD) can be reduced if a surgical left stellate ganglionectomy is performed.
Detailed Summary:
Background: Sudden cardiac death (SCD) is a devastating problem. There is a strong body of evidence which suggests an important role of the autonomic nervous system in the genesis of sudden cardiac death. An increase in vagal tone improves cardiac electrical stability whereas sympathetic hyper-stimulation may precipitate ventricular fibrillation, particularly in the ischaemic heart.
In patients with life threatening ventricular arrhythmias an implanted cardiac defibrillator (ICD) is the treatment of choice. Ventricular arrhythmias can be terminated by either an intra-cardiac shock, often a painful therapy particularly if the patient should remain conscious, or by anti-tachycardia pacing (ATP) which is painless and often is unnoticed.
Despite intensive pharmacological treatment with beta-blockers and often amiodarone, patients may still have up to 20% risk per year of receiving an internal shock for both life threatening and sometimes for a non life threatening arrhythmia. A technique that might reduce the risk of shock delivery over and above current approaches would be an advantage.
It has been suggested that a surgical left stellate ganglionectomy (also referred to as left cardiac sympathetic denervation - LCSD) in patients cardiac arrhythmias may have potential antiarrhythmic benefit particularly in patients with life threatening ventricular arrhythmias and/or at high risk of sudden death (SCD) despite current medical therapy. Recent improvements in surgical techniques has allowed a video assisted minimal access approach (VATS) with a reduction in inpatient stay and increased patient tolerability. The overall risk profile is the same as open thoracotomy but at a much reduced rate.
Current data suggests that LCSD is a reas
Sponsor: Cindy Hall
Current Primary Outcome: Composite outcome measure of intra-cardiac shock frequency and frequency of anti-tachycardia pacing [ Time Frame: 12 months ]
Hypothesis Does video assisted minimal access approach for left cardiac sympathetic denervation in patients with an ICD implanted and on amiodarone for secondary prevention at high risk of sudden death reduce shock frequency and anti-tachycardia pacing compared to optimal medical treatment - a prospective study.
Primary End Point Intra-cardiac shock frequency and frequency of anti-tachycardia pacing over a 12 month period commencing from time of randomisation to a minimum of 365 days post-study entry.
The ICD will be interrogated as per clinical practice prior to signing the Informed Consent form as well as at the 6 and 12 month study follow-up visits. The device will be interrogated within 24 hours of delivery of an intra-cardiac shock or if the patient feels there has been therapy delivery (e.g. ATP).
Original Primary Outcome: Intra-cardiac shock frequency and frequency of anti-tachycardia pacing [ Time Frame: 12 months ]
Hypothesis Does video assisted minimal access approach for left cardiac sympathetic denervation in patients with an ICD implanted and on amiodarone for secondary prevention at high risk of sudden death reduce shock frequency and anti-tachycardia pacing compared to optimal medical treatment - a prospective study.
Primary End Point Intra-cardiac shock frequency and frequency of anti-tachycardia pacing over a 12 month period commencing from time of randomisation to a minimum of 365 days post-study entry.
The ICD will be interrogated as per clinical practice prior to signing the Informed Consent form as well as at the 6 and 12 month study follow-up visits. The device will be interrogated within 24 hours of delivery of an intra-cardiac shock or if the patient feels there has been therapy delivery (e.g. ATP).
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Princess Alexandra Hospital, Brisbane, Australia
Dates:
Date Received: April 7, 2014
Date Started: July 2014
Date Completion:
Last Updated: March 29, 2016
Last Verified: March 2016
