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

Imperial College London

Status

Completed

Conditions

Ventricular Tachycardia

Treatments

Other: Conventional Therapy

Procedure: Robotic VT Ablation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01182389

CRO1631

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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