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Is Left Stellate Ganglionectomy Beneficial to Patients With Life Threatening Ventricular Arrhythmias (Reduce-SCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02113722
Recruitment Status : Withdrawn (Study already undertaken at another centre)
First Posted : April 15, 2014
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Cindy Hall, Princess Alexandra Hospital, Brisbane, Australia

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.

Condition or disease Intervention/treatment Phase
Sudden Cardiac Death Procedure: Left cardiac sympathetic denervation Procedure: Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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
Medical therapy




Primary Outcome Measures :
  1. 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).




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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18yrs old or older.
  • Medical indication for an ICD for secondary prevention as per standard ESC/ACC guidelines.
  • Patients with single, dual chamber or biventricular defibrillators (CRT-D) will be included.
  • Intra-cardiac shock or ATP for VT or VF:

    • For study inclusion the patient must have had a recent intra-cardiac shock or ATP (≤30 days).
    • For study inclusion the patient must be on optimised amiodarone therapy (≥3 months) or have documented evidence of amiodarone intolerance.
    • For study inclusion the Intra-cardiac shock or ATP for VT or VF must not be secondary to a reversible biochemical or drug induced arrhythmia.
  • Ejection fraction of ≤ 40% measured ≤ 6 months prior to the Baseline Visit.
  • Surgical review to ensure patient is suitable for surgery.
  • Women of childbearing potential must have a negative pregnancy test.
  • Written informed consent.

Exclusion Criteria:

  • Age less than 18years.
  • Pregnancy.
  • Predicted life expectancy of less than one year.
  • Intra-cardiac shock or ATP for VT or VF secondary to a reversible biochemical or drug induced arrhythmia.
  • Severe renal impairment with an estimated glomerular filtration rate (eGFR) of less than 20mL/mins.
  • Unsuitable for cardiac surgery.
  • Non-optimised heart failure medications (ACE inhibitors/ARB blockers and/or beta-blockers).

Information from the National Library of Medicine

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


Locations
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Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Sponsors and Collaborators
Cindy Hall
Investigators
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Study Chair: Gerald Kaye, MBBS Princess Alexandra Hospital
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Responsible Party: Cindy Hall, Dr Gerald Kaye, Princess Alexandra Hospital, Brisbane, Australia
ClinicalTrials.gov Identifier: NCT02113722    
Other Study ID Numbers: 14_145
Version 1 dated 12 March 2014 ( Other Identifier: Princess Alexandra Hospital )
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data is de-identified and will not be shared.
Keywords provided by Cindy Hall, Princess Alexandra Hospital, Brisbane, Australia:
Sudden cardiac death
Ganglionectomy
Ventricular arrhythmia
Cardiac surgery
Implanted cardiac defibrillator
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Death
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden