Is Left Stellate Ganglionectomy Beneficial to Patients With Life Threatening Ventricular Arrhythmias

NCT02113722 | Withdrawn DMC

• 2 other identifiers: 14_145Version 1 dated 12 March 2014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Cardiac Death

Keywords

Sudden cardiac death; Ganglionectomy; Ventricular arrhythmia; Cardiac surgery; Implanted cardiac defibrillator

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Study Arms (2)

Left cardiac sympathetic denervation

ACTIVE COMPARATOR

Left cardiac sympathetic denervation

Procedure: Left cardiac sympathetic denervation

Standard of care

PLACEBO COMPARATOR

Continuing medical therapy

Procedure: Standard of Care

Interventions

Left cardiac sympathetic denervation PROCEDURE

Left cardiac sympathetic denervation via a video

Left cardiac sympathetic denervation

Standard of Care PROCEDURE

Medical therapy

Standard of care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Surgical review to ensure patient is suitable for surgery.
• Women of childbearing potential must have a negative pregnancy test.
• Written informed consent.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cindy Hall: lead

Study Sites (1)

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gerald Kaye, MBBS

  Princess Alexandra Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Gerald Kaye

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 15, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 30, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)