A Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia (ERASE-VT)
Primary Purpose
Ventricular Tachycardia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Robotic VT Ablation
Conventional Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Ventricular Tachycardia, Implantable Cardioverter Defibrillator, Catheter Ablation, Robotic
Eligibility 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
Sites / Locations
- St Bartholomew's Hospital
- Hammersmith Hospital, Imperial College Healthcare
- John Radcliffe Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
robotic VT Ablation
Conventional therapy
Arm Description
Robotic VT ablation by substrate elimination
review of ICD programming to ensure that detection and therapy will occur appropriately.
Outcomes
Primary Outcome Measures
Any appropriate ICD therapy
Secondary Outcome Measures
Treatment Failures defined as either2 ICD shocks or 5 ATP episodes
Total therapy rate
Mortality
All cause hospitalisation
Quality of Life
Full Information
NCT ID
NCT01182389
First Posted
August 13, 2010
Last Updated
September 1, 2017
Sponsor
Imperial College London
Collaborators
Hansen Medical
1. Study Identification
Unique Protocol Identification Number
NCT01182389
Brief Title
A Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia
Acronym
ERASE-VT
Official Title
A Prospective Randomised Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Hansen Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Ventricular Tachycardia, Implantable Cardioverter Defibrillator, Catheter Ablation, Robotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
robotic VT Ablation
Arm Type
Active Comparator
Arm Description
Robotic VT ablation by substrate elimination
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
review of ICD programming to ensure that detection and therapy will occur appropriately.
Intervention Type
Procedure
Intervention Name(s)
Robotic VT Ablation
Intervention Description
Robotic VT Ablation
Intervention Type
Other
Intervention Name(s)
Conventional Therapy
Intervention Description
Review of ICD programming to ensure that detection and therapy will occur appropriately
Primary Outcome Measure Information:
Title
Any appropriate ICD therapy
Time Frame
24 months post randomisation
Secondary Outcome Measure Information:
Title
Treatment Failures defined as either2 ICD shocks or 5 ATP episodes
Time Frame
24 months post randomisation
Title
Total therapy rate
Time Frame
24 months post randomisation
Title
Mortality
Time Frame
24 months post randomisation
Title
All cause hospitalisation
Time Frame
24 months post randomisation
Title
Quality of Life
Time Frame
12 months post randomisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prapa Dr Kanagaratnam
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Hammersmith Hospital, Imperial College Healthcare
City
London
ZIP/Postal Code
W120HS
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia
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