Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study

PHASE2SuspendedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 24, 2016

Primary Completion Date

November 30, 2021

Study Completion Date

February 28, 2022

Conditions
Dilated CardiomyopathyIschemic CardiomyopathyNon-ischemic Cardiomyopathy
Interventions
PROCEDURE

Left Cardiac Sympathetic Denervation (LCSD)

The procedure involves the surgical removal of the lower half of the left stellate ganglion (T1) and thoracic ganglia (T2-T4), thereby removing the pro-arrhythmic noradrenergic input to the ventricles

OTHER

Optimal Medical Therapy

"All eligible patients with heart failure and depressed left ventricular systolic function will receive guideline and evidence based optimal tolerated medical therapy. The level of risk associated with optimal medical therapy is considered very low. For the majority of patients with heart failure and depressed left ventricular systolic function this will include:~1. A renin angiotensin system blocker at highest tolerated doses (e.g., enalapril 10mg twice daily or equivalent)~2. A mineralocorticoid receptor antagonist (e.g., Spironolactone 25-50mg daily or equivalent)~3. A Beta-blocker (e.g., Carvedilol 25mg twice daily or equivalent)~4. The use of a loop diuretic and digitalis will be clinically driven and used at the discretion of the attending clinician"

Trial Locations (1)

7925

University of Cape Town, Cape Town

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

lead

University of Cape Town

OTHER