Status:
COMPLETED
A Study of Early Robotic Ablation by Substrate Elimination of Ventricular Tachycardia
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Hansen Medical
Conditions:
Ventricular Tachycardia
Eligibility:
All Genders
18-85 years
Phase:
NA
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 car...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01182389
Start Date
October 1 2011
End Date
February 1 2016
Last Update
September 5 2017
Active Locations (3)
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1
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
2
Hammersmith Hospital, Imperial College Healthcare
London, United Kingdom, W120HS
3
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU