Sudden Cardiac DeathReduce-SCDNCT02113722
Is Left Stellate Ganglionectomy Beneficial to Patients With Life Threatening Ventricular Arrhythmias
A study testing Left cardiac sympathetic denervation in people with Sudden Cardiac Death, run by Cindy Hall at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sudden Cardiac Death
- What is being tested?
- Left cardiac sympathetic denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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 reasonable management option in patients with recurrent ventricular arrhythmias.
Hypothesis: Does VATS assisted LCSD in patients with an ICD implanted for secondary prevention, on chronic amiodarone therapy reduce shock frequency and anti-tachycardia pacing compared to optimal medical treatment - a prospective study.
Protocol: All patients with an ICD who present with an intra-cardiac shock or ATP for the termination of a ventricular arrhythmia (VT or VF) will be eligible for this study. All patients will be established on optimal medical treatment (angiotensin-converting-enzyme (ACE) inhibitor/angiotensin receptor blockers (ARB) and beta blockers) and amiodarone (unless documentation exists of amiodarone intolerance), for three months, as defined in inclusion criteria. Patients will be given the Participant Information Sheet describing the study and signed Informed Consent will be obtained.
Baseline tests will be performed in both groups. Patients will be randomised in a 1:1 fashion to either continued medical treatment or continued medical treatment plus minimal access video assisted left stellate ganglionectomy.
Surgery will be performed within two weeks of randomisation. Surgical patients will be discharged from hospital at the discretion of their treating surgeon. The surgical patients will be assessed in a clinic two weeks after discharge.
All patients will be followed for a total of 365 days from randomisation.
Primary Endpoint:
- 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.
Secondary Endpoints:
- All-cause mortality
- Heart Failure hospital admissions after randomisation
- Early and late surgical complications -
- death
- Horner's syndrome
- length of hospital stay
- post-operative pain
- sweating in the left hand and axilla
- damage to brachial plexus
- Changes in heart rate variability (HRV)
- Inappropriate intra-cardiac shocks for atrial tachyarrhythmias: atrial fibrillation, flutter and tachycardia
- Changes in left ventricular function (ejection fraction) measured by echocardiography
- Changes in heart-to-mediastinum (H/M) ratio on iodine-131-meta-iodobenzineguanidine (MIBG)
- Alterations in the surface twelve lead ECG including:
- change in the QT interval
- changes in QT dispersion on the surface ECG
- changes in QRS duration
- Changes in ICD device derived parameters:
- Frequency of non-sustained ventricular tachycardia and of ventricular premature contractions
- Changes in heart rate variability
- If appropriate (ICD dependent) changes in transthoracic impedance
- Atrial fibrillation burden
- Quality of life assessment (SF36)
Sample Size Sample size will be based upon a projected 10% shock rate in the first 12 months and a mortality of 5-8% (1,2,3). As this is a pilot study the sample will be 25 patients in each group (medical treatment alone vs. LCSD).
- Conditions
- Sudden Cardiac Death
- Being tested
- Left cardiac sympathetic denervation, Standard of Care
- Keywords
- Sudden cardiac death, Ganglionectomy, Ventricular arrhythmia, Cardiac surgery, Implanted cardiac defibrillator
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left cardiac sympathetic denervationProcedure or surgery
Left cardiac sympathetic denervation via a video
Standard of CareProcedure or surgery
Medical therapy
| Study group | Role | What they receive |
|---|---|---|
| Left cardiac sympathetic denervation | Active comparator | Left cardiac sympathetic denervation Receives: Procedure: Left cardiac sympathetic denervation |
| Standard of care | Placebo comparator | Continuing medical therapy Receives: Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome measure of intra-cardiac shock frequency and frequency of anti-tachycardia pacing
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Study already undertaken at another centre
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cindy Hall
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cindy Hall, Princess Alexandra Hospital, Brisbane, Australia
- Investigators
- Gerald Kaye, MBBS, Study chair, Princess Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113722
- Sponsor's protocol ID
- 14_145
- Other IDs
- Version 1 dated 12 March 2014
- Acronym
- Reduce-SCD
- Status last verified
- Mar 2016
- First submitted
- 7 Apr 2014
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data is de-identified and will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02113722
- Acronym / sponsor ID
- Reduce-SCD / 14_145
- Conditions
- Sudden Cardiac Death
- Keywords
- Sudden cardiac death, Ganglionectomy, Ventricular arrhythmia, Cardiac surgery, Implanted cardiac defibrillator
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study already undertaken at another centre
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cindy HallUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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 reasonable management option in patients with recurrent ventricular arrhythmias.
Hypothesis: Does VATS assisted LCSD in patients with an ICD implanted for secondary prevention, on chronic amiodarone therapy reduce shock frequency and anti-tachycardia pacing compared to optimal medical treatment - a prospective study.
Protocol: All patients with an ICD who present with an intra-cardiac shock or ATP for the termination of a ventricular arrhythmia (VT or VF) will be eligible for this study. All patients will be established on optimal medical treatment (angiotensin-converting-enzyme (ACE) inhibitor/angiotensin receptor blockers (ARB) and beta blockers) and amiodarone (unless documentation exists of amiodarone intolerance), for three months, as defined in inclusion criteria. Patients will be given the Participant Information Sheet describing the study and signed Informed Consent will be obtained.
Baseline tests will be performed in both groups. Patients will be randomised in a 1:1 fashion to either continued medical treatment or continued medical treatment plus minimal access video assisted left stellate ganglionectomy.
Surgery will be performed within two weeks of randomisation. Surgical patients will be discharged from hospital at the discretion of their treating surgeon. The surgical patients will be assessed in a clinic two weeks after discharge.
All patients will be followed for a total of 365 days from randomisation.
Primary Endpoint:
- 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.
Secondary Endpoints:
- All-cause mortality
- Heart Failure hospital admissions after randomisation
- Early and late surgical complications -
- death
- Horner's syndrome
- length of hospital stay
- post-operative pain
- sweating in the left hand and axilla
- damage to brachial plexus
- Changes in heart rate variability (HRV)
- Inappropriate intra-cardiac shocks for atrial tachyarrhythmias: atrial fibrillation, flutter and tachycardia
- Changes in left ventricular function (ejection fraction) measured by echocardiography
- Changes in heart-to-mediastinum (H/M) ratio on iodine-131-meta-iodobenzineguanidine (MIBG)
- Alterations in the surface twelve lead ECG including:
- change in the QT interval
- changes in QT dispersion on the surface ECG
- changes in QRS duration
- Changes in ICD device derived parameters:
- Frequency of non-sustained ventricular tachycardia and of ventricular premature contractions
- Changes in heart rate variability
- If appropriate (ICD dependent) changes in transthoracic impedance
- Atrial fibrillation burden
- Quality of life assessment (SF36)
Sample Size Sample size will be based upon a projected 10% shock rate in the first 12 months and a mortality of 5-8% (1,2,3). As this is a pilot study the sample will be 25 patients in each group (medical treatment alone vs. LCSD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left cardiac sympathetic denervation | Active comparator | Procedure: Left cardiac sympathetic denervationLeft cardiac sympathetic denervation |
| Standard of care | Placebo comparator | Procedure: Standard of CareContinuing medical therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Ejection fraction of ≤ 40% measured ≤ 6 months prior to the Baseline Visit.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left cardiac sympathetic denervationLeft cardiac sympathetic denervation via a video | Procedure or surgery | Left cardiac sympathetic denervation |
| Standard of CareMedical therapy | Procedure or surgery | Standard of care |
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Individual participant dataSharing planned: No. Data is de-identified and will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Kaye, MBBS study chair
Princess Alexandra Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left cardiac sympathetic denervation in people with Sudden Cardiac Death, run by Cindy Hall at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome measure of intra-cardiac shock frequency and frequency of anti-tachycardia pacing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.