STAR-VT
Research type
Research Study
Full title
Substrate Targeted Ablation using the FlexAbility Ablation Catheter System for the Reduction of Ventricular Tachycardia
IRAS ID
162100
Contact name
Francis Murgatroyd
Contact email
Sponsor organisation
St Jude Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
This study aims to demonstrate that a procedure called ventricular tachycardia (VT) catheter ablation performed using the new FlexAbility ablation catheter will benefit patients who suffer from or are susceptible to a certain type of heart rhythm abnormality, and who are receiving an implantable cardiac defibrillator (ICD) .
The current standard treatment for these patients is anti-arrhythmia medication and an ICD implant. The medication is to prevent VT episodes which can lead to sudden cardiac death. The ICD detects a VT episode if one occurs, and delivers a shock to return the heart to a normal rhythm. However, many patients who receive this standard treatment unfortunately still experience VT and get shocked, or get shocked inappropriately when not having a VT event. ICD shocks are also associated with increased mortality, hospitalisations, and impaired quality of life.
This study will enrol patients who have recently received an ICD implant or who are waiting to receive one shortly. The patients will be further evaluated to determine whether they have already had a type of VT called monomorphic VT (MMVT) or if they are susceptible to it by performing a test. For those who are not susceptible to MMVT, they will enter a registry which will only track their ICD shocks and basic follow-up data through 12 months. Those with VT will be randomised to either undergo the ablation procedure or not; both groups will continue taking their anti-arrhythmia medication too. The clinical outcomes of these two groups will be compared up through 12 months, particularly the occurrence of ICD shocks, to see if the ablation group had better outcomes.
The study will also detect if there are any safety issues with the new FlexAbility ablation catheter and associated Ampere generator, particularly in epicardial ablation procedures for which these products do not have CE Mark approval. If the safety results are acceptable, they will be put forward for market approval for standard use in both endocardial and epicardial ablation procedures.
REC name
London - Dulwich Research Ethics Committee
REC reference
15/LO/1070
Date of REC Opinion
11 Aug 2015
REC opinion
Further Information Favourable Opinion