Biosense Webster has completed patient enrolment for its SMART-AF investigational device exemption (IDE) study. One hundred and seventy three patients were enrolled at leading centres across the United States.
The SMART-AF study is designed to demonstrate the safety and effectiveness of the Thermocool Smarttouch catheter in the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation.
The Thermocool Smarttouch measures the contact force and direction that the catheter exerts on the heart tissue in real time. As the size of therapeutic radiofrequency lesions is affected by the extent of contact, the ability for physicians to directly measure contact force, rather than having to rely on surrogate measures, represents an important advance in catheter technology.
“The Thermocool Smarttouch catheter has been performing extremely well during my SMART-AF cases. The ability to measure contact force and direction in real time, as I map and ablate, is enabling me to maneuver the catheter confidently, and is becoming a key measure in my procedures. Additionally, the integration of this technology into the Carto 3 mapping and navigation system facilitates incorporation into my workflow,” said David Wilber, director of Cardiology at Loyola University, USA, and a member of the SMART-AF study advisory committee.