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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Imperial College London
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
  Purpose

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 Intervention
Ventricular Tachycardia
Procedure: Robotic VT Ablation
Other: Conventional Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomised Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Any appropriate ICD therapy [ Time Frame: 24 months post randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182389

Contacts
Contact: Andrew Copley, BSc (Hons) +442033122007 a.copley@imperial.ac.uk

Locations
United Kingdom
St Mary's Hospital Recruiting
London, United Kingdom, W2 1NY
Contact: Andrew Copley, BSc (Hons)    +442033122007    a.copley@imperial.ac.uk   
Principal Investigator: Dr Prapa Kanagaratnam         
St Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Contact: Prof. Richard Schilling         
Principal Investigator: Prof. Richard Schilling         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Dr Kim Rajappan         
Principal Investigator: Dr Kim Rajappan         
Sponsors and Collaborators
Imperial College London
Hansen Medical
Investigators
Principal Investigator: Prapa Dr Kanagaratnam Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01182389     History of Changes
Other Study ID Numbers: CRO1631
Study First Received: August 13, 2010
Last Updated: September 12, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 28, 2014