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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01182389
Recruitment Status : Completed
First Posted : August 16, 2010
Last Update Posted : September 5, 2017
Hansen Medical
Information provided by (Responsible Party):
Imperial College London

Brief 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.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Procedure: Robotic VT Ablation Other: Conventional Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia
Study Start Date : October 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Any appropriate ICD therapy [ Time Frame: 24 months post randomisation ]

Secondary Outcome Measures :
  1. Treatment Failures defined as either2 ICD shocks or 5 ATP episodes [ Time Frame: 24 months post randomisation ]
  2. Total therapy rate [ Time Frame: 24 months post randomisation ]
  3. Mortality [ Time Frame: 24 months post randomisation ]
  4. All cause hospitalisation [ Time Frame: 24 months post randomisation ]
  5. Quality of Life [ Time Frame: 12 months post randomisation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01182389

United Kingdom
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Hammersmith Hospital, Imperial College Healthcare
London, United Kingdom, W120HS
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Imperial College London
Hansen Medical
Principal Investigator: Prapa Dr Kanagaratnam Imperial College London

Responsible Party: Imperial College London Identifier: NCT01182389     History of Changes
Other Study ID Numbers: CRO1631
First Posted: August 16, 2010    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: February 2016

Keywords provided by Imperial College London:
Ventricular Tachycardia
Implantable Cardioverter Defibrillator
Catheter Ablation

Additional relevant MeSH terms:
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes