ARTISAN AF

  • Research type

    Research Study

  • Full title

    A prospective, single arm study of the Hansen System for introducing and positioning the RF ablation catheters in subjects with paroxysmal atrial fibrillation

  • IRAS ID

    155918

  • Contact name

    Kumaran (Kim) Rajappan

  • Contact email

    kim.rajappan@ouh.nhs.uk

  • Sponsor organisation

    Hansen Medical, Inc

  • Clinicaltrials.gov Identifier

    NCT01122173

  • Research summary

    Atrial fibrillation is an irregular and often rapid heart rate that commonly causes poor blood flow to the body. Ablation therapy can be used to treat atrial fibrillation by using electrical energy to burn small areas of heart tissue.
    Catheter ablation of atrial fibrillation uses electrical energy to destroy the heart tissue that starts the atrial fibrillation. This is called radiofrequency catheter ablation. Radiofrequency catheter ablation is a procedure that delivers electrical energy through a catheter that is in direct contact with small areas of the heart muscle. The electrical energy heats the heart tissue and results in a small, localised burn. Burning of the heart tissue results in destruction of that targeted portion of the heart muscle; by destroying the area of muscle which may be responsible for starting or maintaining the atrial fibrillation, it is hoped that the arrhythmia will be eliminated (stopped).

    Hansen Medical, Inc. has developed the Hansen Medical Sensei X Robotic System and family of Artisan guide catheters (also referred to as the Hansen System). The Hansen System is intended to facilitate manipulation, positioning and control of catheters to be used within the atria (upper compartments) of the heart.

    The Hansen Medical System has CE-marking, meaning that it is approved for commercial use in the European Union during ablation procedures with a variety of ablation catheters, all of which also have CE marking.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    14/WM/1101

  • Date of REC Opinion

    29 Sep 2014

  • REC opinion

    Further Information Favourable Opinion