Clinical Trial: Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Multi-center, Randomized, Controlled Trial to Compare Feasibility, Safety and Efficacy of Zero-Fluoroscopic Navigation With Conventional Fluoroscopic Navigation for Single-chamber Pacemaker Implantati

Brief Summary: 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 single-chamber pacemaker implantation.

Detailed Summary:

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.


Sponsor: Tongji Hospital

Current Primary Outcome: Success rate [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total procedure time [ Time Frame: during procedure ]
  • Fluoroscopy time [ Time Frame: during procedure ]
  • Complications [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Tongji Hospital

Dates:
Date Received: April 13, 2017
Date Started: January 2013
Date Completion: December 2020
Last Updated: April 13, 2017
Last Verified: April 2017