Bradycardia Clinical Trial
Official title:
Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation
This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing double-chamber pacemaker implantation.
Permanent pacemaker is a well-established treatment to treat patients with a wide range of
heart rhythm disturbances.
Fluoroscopy is the imaging modality routinely used for cardiac device implantation and
electrophysiological procedures.Due to the rising concern regarding the harmful effects of
radiation exposure to both the patients and operation staffs, novel 3D mapping systems have
been developed and implemented in electrophysiological procedure for the navigation of
catheters inside the heart chambers.
Ensite NavX system can be used for cardiac imaging as a reliable and safe zero-fluoroscopy
approach for implantation of single- or dual-chamber permanent pacemaker in patients. Our
method offered a choice for some special population of patient in whom radiation exposure
need to be avoided or in the extreme circumstances when the X-ray machine is out-of-order.
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