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

NCT01182389 | Completed DMC

• 1 other identifier: CRO1631
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

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.

Conditions

Ventricular Tachycardia

Keywords

Ventricular Tachycardia; Implantable Cardioverter Defibrillator; Catheter Ablation; Robotic

Outcome Measures

Primary Outcomes (1)

• Any appropriate ICD therapy

  24 months post randomisation

Secondary Outcomes (5)

• Treatment Failures defined as either2 ICD shocks or 5 ATP episodes

  24 months post randomisation

• Total therapy rate

  24 months post randomisation

• Mortality

  24 months post randomisation

• All cause hospitalisation

  24 months post randomisation

• Quality of Life

  12 months post randomisation

Study Arms (2)

robotic VT Ablation

ACTIVE COMPARATOR

Robotic VT ablation by substrate elimination

Procedure: Robotic VT Ablation

Conventional therapy

ACTIVE COMPARATOR

review of ICD programming to ensure that detection and therapy will occur appropriately.

Other: Conventional Therapy

Interventions

Robotic VT Ablation PROCEDURE

Robotic VT Ablation

robotic VT Ablation

Conventional Therapy OTHER

Review of ICD programming to ensure that detection and therapy will occur appropriately

Conventional therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Hansen Medical: collaborator

Study Sites (3)

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Hammersmith Hospital, Imperial College Healthcare

London, W120HS, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prapa Dr Kanagaratnam

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 16, 2010
• Study Start: October 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: September 5, 2017

Record last verified: 2016-02

Locations

GB (3)