EFFECTIVE PAF
Research type
Research Study
Full title
Efficacy, Safety and Efficiency of the nMARQ Pulmonary Vein Isolation System in the treatment of Paroxysmal Atrial Fibrillation - A Pilot Study
IRAS ID
134455
Contact name
Stuart Tan
Contact email
Sponsor organisation
Basildon and Thurrock University Hospital
Research summary
This is a pilot study designed to investigate the effectiveness of the nMARQ Pulmonary Vein Isolation system in the treatment of Paroxysmal AF at different ablation settings.\n\nAtrial Fibrillation is a common condition which causes a fast and erratic heartbeat. There are estimated to be 50,000 new cases diagnosed per year in the UK. The fast heart beat can cause symptoms such as palpitations, light-headedness, chest pains, shortness of breath and fatigue. \n\nCatheter ablation is a technique used for control of AF. In this procedure a catheter (a long thin wire) is passed into the chambers of the heart via a large blood vessel in a leg. The tip of the catheter can destroy tiny sections of heart tissue that may be the source or trigger of the abnormal electrical impulses. One of the challenges of AF ablation is to maximise sucess rates, as such, there is currently rapid advances in technology to carry out this procedure.\n\nDifferent catheters exist which deliver this energy in different ways. This study uses one such system to perform this procedure. It is called the nMARQ system for Pulmonary Vein Isolation produced by Biosense Webster. Currently this system is used in practice in the UK for patients with this medical condition. \n\nWhat we seek to research is, when ablating what is the optimum setting to perform ablation at. There is currently no data to guide best clinical practice in this area.\n\nThe study centre will be the Essex Cardiothoracic Centre.\n\nThe study will be open until recruitment of 60 patients (estimated to be less than 12 months). \n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0428
Date of REC Opinion
17 Feb 2014
REC opinion
Further Information Favourable Opinion