Is Left Stellate Ganglionectomy Beneficial to Patients With Life Threatening Ventricular Arrhythmias (Reduce-SCD)
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|ClinicalTrials.gov Identifier: NCT02113722|
Recruitment Status : Withdrawn (Study already undertaken at another centre)
First Posted : April 15, 2014
Last Update Posted : March 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sudden Cardiac Death||Procedure: Left cardiac sympathetic denervation Procedure: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|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 Patients at High Risk of Sudden Cardiac Death|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Active Comparator: Left cardiac sympathetic denervation
Left cardiac sympathetic denervation
Procedure: Left cardiac sympathetic denervation
Left cardiac sympathetic denervation via a video
Placebo Comparator: Standard of care
Continuing medical therapy
Procedure: Standard of Care
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113722
|Princess Alexandra Hospital|
|Brisbane, Queensland, Australia, 4102|
|Study Chair:||Gerald Kaye, MBBS||Princess Alexandra Hospital|