LESS-VT
Research type
Research Study
Full title
FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT (LESS-VT) Study
IRAS ID
244931
Contact name
Magdi Saba
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 11 months, 2 days
Research summary
Catheter ablation is a form of therapy used to treat ventricular tachycardia (VT), a broad complex tachycardia (a heart that exceeds the normal resting rate), originating in the ventricles (the large, lower chambers of the heart). Cardiac ablation for VT is a procedure that involves using a catheter (a thin, flexible tube that can be threaded through the blood vessels to the heart) to deliver radiofrequency energy (a type of heat) to one or more areas in the ventricles of heart that are causing the irregular heartbeat. The tip of the catheter transmits energy to one or more small spots of heart tissue. This energy creates a small scar on the heart. This scar will block the electrical pathway that is causing the rapid heartbeat.
The purpose of the study is to show that the FlexAbility™ SE Ablation Catheter is safe and effective in reducing the number of VT episodes in patients who continue to experience VT despite taking antiarrhythmic medications (medicines to prevent abnormal heart rhythms), or who are unable to take antiarrhythmic medications.
The FlexAbility™ SE Ablation Catheter is approved in the United States to treat irregular heartbeats in the atria (upper chambers of the heart). This study is testing use of the same catheter to treat VT and is therefore considered experimental in the United States.
The FlexAbility™ SE Ablation Catheter is approved in other countries to treat irregular heartbeats in the atria (upper chambers of the heart) and ventricles (lower chambers of the heart). This study is collecting data on the use of the FlexAbility™ SE Ablation Catheter to treat VT and will be submitted for review and approval by the United States Food and Drug Administration (FDA).
The study is designed to collect data that will demonstrate that catheter ablation with FlexAbility™ SE is safe and effective as catheter ablation using catheters already approved for VT ablation in the United States and many other countries (control catheters). These control catheters are approved for the treatment of VT caused by ischemic cardiomyopathy (ICM), a type of VT that occurs as a result of weakened heart muscle due to heart attack or coronary artery disease, where the arteries that supply blood to the heart muscle become narrowed. Therefore, VT caused by ICM will be randomly assigned to undergo VT ablation using either the FlexAbility™ SE Ablation Catheter or one of the control catheters.
The study is also designed to collect data that will demonstrate that catheter ablation with FlexAbility™ SE is safe and effective for treatment of VT of non-ischemic origin (NICM), when the VT is not related to known coronary artery disease, but can be due to inherited heart disease. Since there are no control catheters approved for treatment of VT caused by NICM, subjects with VT caused by NICM will receive ablation with the FlexAbility™ SE Ablation catheter, and safety and effectiveness data will be compared to known safety and effectiveness of currently approved treatment methods for this disease that have been published in medical literature.
REC name
London - City & East Research Ethics Committee
REC reference
19/LO/0316
Date of REC Opinion
31 May 2019
REC opinion
Further Information Favourable Opinion