NCT01182389

A Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia

A Prospective Randomised Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

Ventricular tachycardia (VT) is an abnormal rapid heartbeat which occurs after a heart attack and can cause sudden death. Patients at risk of this rhythm disturbance usually receive an implantable cardioverter defibrillator (ICD) that can prevent death by returning the heart's rhythm back to normal by electrically stimulating the heart but in doing so gives the patient painful and debilitating shocks. The first ICD shock after implantation appears to be a powerful predictor of subsequent shock therapy as well as being a predictor of of increased mortality in patients with primary prevention ICDs. In patients who receive repeated shocks VT ablation is performed to 'burn' the abnormal area of the heart that causes the problem. However, it is often only performed as a last resort as it is technically challenging. We believe that performing VT ablation using the robotic system early after the first episode of VT after ICD implantation, may reduce the number of painful shocks received by the patient and possibly increase life expectancy and quality of life. 200 patients from 5 european countries will be recruited in a prospective, open, randomised trial. Eligible, consenting patients who have experienced their first episode of VT since ICD implantation, will be randomised in a 1:1 manner into treatment arms of either VT ablation or standard 'conventional' therapy and followed-up every 4 months over two years to assess the number of subsequent ICD shocks, hospitalisation, mortality and quality of life.

Conditions

• Ventricular Tachycardia

Interventions

Type	Name	Description
PROCEDURE	Robotic VT Ablation	Robotic VT Ablation
OTHER	Conventional Therapy	Review of ICD programming to ensure that detection and therapy will occur appropriately

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-12-01
• Completion: 2016-02-01
• First posted: 2010-08-16
• Last updated: 2017-09-05

Locations

3 sites across 1 country: United Kingdom