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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02113722




Registration number
NCT02113722
Ethics application status
Date submitted
7/04/2014
Date registered
15/04/2014

Titles & IDs
Public title
Is Left Stellate Ganglionectomy Beneficial to Patients With Life Threatening Ventricular Arrhythmias
Scientific 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
Secondary ID [1] 0 0
Version 1 dated 12 March 2014
Secondary ID [2] 0 0
14_145
Universal Trial Number (UTN)
Trial acronym
Reduce-SCD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sudden Cardiac Death 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Left cardiac sympathetic denervation
Treatment: Surgery - Standard of Care

Active comparator: Left cardiac sympathetic denervation - Left cardiac sympathetic denervation

Placebo comparator: Standard of care - Continuing medical therapy


Treatment: Surgery: Left cardiac sympathetic denervation
Left cardiac sympathetic denervation via a video

Treatment: Surgery: Standard of Care
Medical therapy
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite outcome measure of intra-cardiac shock frequency and frequency of anti-tachycardia pacing
Timepoint [1] 0 0
12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4102 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Cindy Hall
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerald Kaye, MBBS
Address 0 0
Princess Alexandra Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is de-identified and will not be shared.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02113722