Clinical Trial: Zero Fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for Right Atrial Arrhythmias

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 the Ablation of Right Atrial Arrhyt

Brief Summary: This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach with conventional fluoroscopic approach as performing catheter ablation of right atrial arrhythmias.

Detailed Summary:

Catheter ablation 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 three-dimensional mapping systems such as Ensite NavX have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers.

Ensite NavX is a promising system to guide catheters inside the cardiac chambers and vessels without the use of fluoroscopy.

This study is intended to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach with conventional fluoroscopic approach as performing catheter ablation of right atrial arrhythmias.


Sponsor: Tongji Hospital

Current Primary Outcome: Total success rates [ 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: 6 months ]
  • Immediate success rate [ Time Frame: 24 hours ]
  • Recurrence rate [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Tongji Hospital

Dates:
Date Received: May 11, 2017
Date Started: January 2011
Date Completion: December 2018
Last Updated: May 11, 2017
Last Verified: May 2017