An interventional study of zero-fluoroscopy 3D navigation and conventional x-ray navigation in Sick Sinus Syndrome, Complete Atrioventricular Block and High Degree Second Degree Atrioventricular Block (Disorder), sponsored by Tongji Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-04-18.
Sponsored by Tongji Hospital · Not applicable, Interventional, and Treatment
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.
306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.
This study's planned enrollment of 100 is close to the median of 99 across 174 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pacemaker implantation performed for all patients in this group with zero-fluoroscopy 3D navigation.
Procedure: zero-fluoroscopy 3D navigation
Pacemaker implantation performed for all patients with conventional x-ray navigation.
Procedure: conventional x-ray navigation
Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.
Also known as: non-fluoroscopy 3D navigation
Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.
Also known as: fluoroscopy navigation
Success rate
Time frame: 3 months
Total procedure time
Time frame: during procedure
Fluoroscopy time
Time frame: during procedure
Complications
Time frame: 1 year
Plan to share: No
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Tongji Hospital