A Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia (ERASE-VT)

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

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Procedure: Robotic VT Ablation; Other: Conventional Therapy

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • St Bartholomew'S Hospital
  • London, United Kingdom, W120HS
    • Hammersmith Hospital, Imperial College Healthcare
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males or females eighteen (18) to eighty-five (85) years old
• ICD implantation for post-infarct primary or secondary prophylaxis
• First episode of VT detected (within monitor zone or therapy (ATP /shock delivered) or by 12 lead ECG if the rate below the detection level of the device.
• Suitable candidate for catheter ablation
• Signed informed consent

Exclusion Criteria:

• Contraindication to catheter ablation
• Ventricular tachycardia due to transient, reversible causes
• Presence of a left ventricular thrombus
• Severe cerebrovascular disease
• Active gastrointestinal bleeding
• Renal failure (on dialysis or at risk of requiring dialysis)
• Active infection or fever
• Life expectancy shorter than the duration of the trial
• Allergy to contrast
• Intractable heart failure (NYHA Class IV)
• Bleeding or clotting disorders or inability to receive heparin
• Serum [K+] <3.5 or >5.0mmol/L
• Serum Creatinine >200umol/L
• Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≤64mmol/mol and Fasting Blood Glucose ≥9.2mmol/L)
• Malignancy needing therapy
• Pregnancy or women of child-bearing potential not using a highly effective method of contraception
• Unable to give informed consent
• Unable to attend follow-up in ICD clinics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: robotic VT Ablation; Robotic VT ablation by substrate elimination	Procedure: Robotic VT Ablation; Robotic VT Ablation
ACTIVE_COMPARATOR: Conventional therapy; review of ICD programming to ensure that detection and therapy will occur appropriately.	Other: Conventional Therapy; Review of ICD programming to ensure that detection and therapy will occur appropriately

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Any appropriate ICD therapy	24 months post randomisation

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment Failures defined as either2 ICD shocks or 5 ATP episodes	24 months post randomisation
Total therapy rate	24 months post randomisation
Mortality	24 months post randomisation
All cause hospitalisation	24 months post randomisation
Quality of Life	12 months post randomisation

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Hansen Medical
• Investigators: Principal Investigator: Prapa Dr Kanagaratnam, Imperial College London

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: August 13, 2010
• First Submitted That Met QC Criteria: August 13, 2010
• First Posted (ESTIMATE): August 16, 2010

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Catheter Ablation; Robotic; Ventricular Tachycardia; Implantable Cardioverter Defibrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: CRO1631