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Clinical Trials/NCT01182389
NCT01182389
Completed
Not Applicable

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

Imperial College London3 sites in 1 country51 target enrollmentOctober 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventricular Tachycardia
Sponsor
Imperial College London
Enrollment
51
Locations
3
Primary Endpoint
Any appropriate ICD therapy
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
February 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Any appropriate ICD therapy

Time Frame: 24 months post randomisation

Secondary Outcomes

  • Mortality(24 months post randomisation)
  • Treatment Failures defined as either2 ICD shocks or 5 ATP episodes(24 months post randomisation)
  • Total therapy rate(24 months post randomisation)
  • All cause hospitalisation(24 months post randomisation)
  • Quality of Life(12 months post randomisation)

Study Sites (3)

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