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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hansen Medical
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01182389
First received: August 13, 2010
Last updated: September 12, 2012
Last verified: September 2012

August 13, 2010
September 12, 2012
October 2011
October 2014   (final data collection date for primary outcome measure)
Any appropriate ICD therapy [ Time Frame: 24 months post randomisation ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01182389 on ClinicalTrials.gov Archive Site
  • Treatment Failures defined as either2 ICD shocks or 5 ATP episodes [ Time Frame: 24 months post randomisation ] [ Designated as safety issue: No ]
  • Total therapy rate [ Time Frame: 24 months post randomisation ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 24 months post randomisation ] [ Designated as safety issue: No ]
  • All cause hospitalisation [ Time Frame: 24 months post randomisation ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 12 months post randomisation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ventricular Tachycardia
  • Procedure: Robotic VT Ablation
    Robotic VT Ablation
  • Other: Conventional Therapy
    Review of ICD programming to ensure that detection and therapy will occur appropriately
  • Active Comparator: robotic VT Ablation
    Robotic VT ablation by substrate elimination
    Intervention: Procedure: Robotic VT Ablation
  • Active Comparator: Conventional therapy
    review of ICD programming to ensure that detection and therapy will occur appropriately.
    Intervention: Other: Conventional Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
Yes
Contact: Andrew Copley, BSc (Hons) +442033122007 a.copley@imperial.ac.uk
United Kingdom
 
NCT01182389
CRO1631
Yes
Imperial College London
Imperial College London
Hansen Medical
Principal Investigator: Prapa Dr Kanagaratnam Imperial College London
Imperial College London
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP